| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
You are here Biopharmaceuticals Glossary Homepage/Search > Business > Drug discovery & development > Regulatory Affairs Regulatory Affairs:
drugs, devices, diagnostics Glossary & taxonomy
Drug
discovery term index Finding guide to terms in these glossaries Site Map Ethics
This is a sub-category of Drug discovery &
development
Related glossaries include Biologics
Clinical trials Drug safety &
pharmacovigilance Molecular Medicine Pharmacogenomics Informatics Clinical
informatics Research
Technologies: Bioprocessing 21 CFR Part 11, Electronic
records, Electronic signatures, Office
of Regulatory Affairs ORA, FDA http://www.fda.gov/ora/compliance_ref/part11/ 21 CFR Part 50 Human
Subject Protection Informed Consent :
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50 21 CFR Part 56
Institutional Review Boards IRBs http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56 510(K) A premarketing submission made to FDA to
demonstrate that the device to be marketed is as safe and effective, that is,
substantially equivalent (SE), to a legally marketed device that is not subject
to premarket approval (PMA). Applicants must compare their 510(k) device to one
or more similar devices currently on the U.S. market and make and support their
substantial equivalency claims. A legally marketed device is a device that was
legally marketed prior to May 28, 1976 (preamendments device), or a device which
has been reclassified from Class III to Class II or I, a device which has been
found to be substantially equivalent to such a device through the 510(k)
process, or one established through Evaluation of Automatic Class III
Definition. The legally marketed device(s) to which equivalence is drawn is
known as the "predicate" device(s). FDA, Center for Devices and
Radiologic Health, 2004 http://www.fda.gov/cdrh/devadvice/314.html A 510(k) application involves demonstrating that the new product is substantially equivalent to an existing product on the market. It is limited to devices and diagnostics, and by definition, applies only to "me- too" type devices. That is, it represents an incremental improvement over something that is already on the market ... Because of its similarity to a product that has already had a thorough regulatory review, it does not bring up any new issues. .. For 510(k)s, we [the FDA] have been averaging about 1,000 a year. Joseph Hackett, in CHI Summit Pharmacogenomics Report accelerated approval: in 1992 FDA instituted the Accelerated Approval regulation, allowing earlier approval of drugs to treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker - a laboratory measurement, or physical sign - that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome, such as survival or symptom improvement. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Approval of a drug based on such endpoints is given on the condition that post marketing clinical trials verify the anticipated clinical benefit. http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm analyte
specific reagents: Antibodies,
both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic
acid sequences, and similar reagents which, through specific binding or chemical
reaction with substances in a specimen, are intended for use in a diagnostic
application for identification and quantification of an individual chemical
substance or ligand in biological specimens. Title
21 Food and Drugs Chapter
I FDA Dept HHS Subchapter H Medical Devices Part 809 IN VITRO DIAGNOSTIC
PRODUCTS FOR HUMAN USE Subpart C--Requirements for Manufacturers and Producers http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=809.30 bioequivalence: Scientific basis on which generic and brand- name drugs are compared. To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions. Some drugs, however, are intended to have a different absorption rate. FDA may consider a product bioequivalent to a second product with a different rate of absorption if the difference is noted in the labeling and doesn't affect the drug's safety or effectiveness or change the drug's effects in any medically significant way. Drug Review Glossary, FDA Consumer Magazine, 25 definitions http://www.fda.gov/fdac/special/newdrug/bengloss.html See also therapeutic equivalency bioinequivalence: www.fda.gov/ohrms/DOCKETS/ac/04/slides/2004-4078S2_07_YU.ppt biogenerics:
So far, drugs based on large biological molecules
have been immune from copycat competition since most are still patent- protected
and, critically, regulators in major markets have yet to set clear rules for
approving generic versions. But so- called "biogenerics" are gaining a
foothold in Asia, where patents on original versions have expired or patent
protection does not exist, and generics firms are looking hungrily at Europe as
their next major outlet. Ben Hirschler, Biotech drug copycats get ready to
pounce, San Diego Union Tribune, Sept, 18, 2002 http://www.signonsandiego.com/news/business/biotech/
20020918-0547-health-biotech-generics.html biopharmaceutical:
Biologics biosimilars:
Biosimilars and
Biobetters March 19-20, 2012 • Baltimore, MD Program | Register | Download
Brochure biological products, which are biological prescription drugs that
are demonstrated to be “highly similar” (biosimilar) to or
“interchangeable” with an FDA-approved biological product. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm Related terms: analogues,
biogenerics, follow ons, generics, me-toos biotechnology: Genetic manipulation &
disruption
Biologics borderline products: Products which are close to
the boundary between medicines, which need a licence, and others, such as
nutritional supplements, cosmetics etc., which do not. Classification depends
either on the ingredient or the claim or both. Medicines Control Agency, UK,
Pilot publication scheme, Glossary of terms, 2003 http://www.mca.gov.uk/pilot/app1.htm#A brand
name drug: A drug marketed under a proprietary, trademark-
protected name. Glossary, Drugs@FDA,
CDER, 2004 http://www.fda.gov/cder/drugsatfda/glossary.htm bundling: Refers to the inclusion of
multiple devices or multiple indications for use for a device in a single
premarket submission, including products subject to the device and biologics
license application (BLA) authorities, for purposes of review and user fee
payment. In CBER, the term may also include the designation of separate
submissions as one premarket submission for review and user fee payment.
Multiple devices may include different models within a generic type of device2
or devices that are of differing generic types. Center for Devices &
Radiological Health, FDA, Guidance for Industry and FDA Staff: Bundling Multiple
Devices or Multiple Indications in a Single Submission, 2003. http://www.fda.gov/cdrh/mdufma/guidance/1215.html#2a CBER Center for Biologics
Evaluation and Research: CBER is the Center within FDA that regulates
biological products for human use under applicable federal laws, including the
Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER
protects and advances the public health by ensuring that biological products are
safe and effective and available to those who need them. http://www.fda.gov/AboutFDA/CentersOffices/CBER/default.htm
Categories of Therapeutic Biological Products Remaining in CBER Cellular
products, including products composed of human, bacterial or animal cells (such
as pancreatic islet cells for transplantation), or from physical parts of those
cells (such as whole cells, cell fragments, or other components intended for use
as preventative or therapeutic vaccines). Gene therapy products. Human gene
therapy/gene transfer is the administration of nucleic acids, viruses, or
genetically engineered microorganisms that mediate their effect by transcription
and/or translation of the transferred genetic material, and/or by integrating
into the host genome. Cells may be modified in these ways ex vivo for subsequent
administration to the recipient, or altered in vivo by gene therapy products
administered directly to the recipient. Vaccines (products intended to induce or
increase an antigen specific immune response for prophylactic or therapeutic
immunization, regardless of the composition or method of manufacture). Allergenic
extracts used for the diagnosis and treatment of allergic diseases and allergen
patch tests. Antitoxins, antivenins, and venoms Blood, blood components, plasma
derived products (for example, albumin, immunoglobulins, clotting factors,
fibrin sealants, proteinase inhibitors), including recombinant and transgenic
versions of plasma derivatives, (for example clotting factors), blood
substitutes, plasma volume expanders, human or animal polyclonal antibody
preparations including radiolabeled or conjugated forms, and certain
fibrinolytics such as plasma-derived plasmin, and red cell reagents. CDER Center for Drug Evaluation and Research: As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. http://www.fda.gov/cder/ Categories of Therapeutic Biological Products Transferred to CDER from CBER, June 30, 2003: Monoclonal antibodies for in-vivo use, Proteins intended for therapeutic use, including cytokines (e.g. interferons), enzymes (e.g. thrombolytics), and other novel proteins, except for those that are specifically assigned to CBER (e.g., vaccines and blood products). This category includes therapeutic proteins derived from plants, animals, or microorganisms, and recombinant versions of these products. Immunomodulators (non-vaccine and non-allergenic products intended to treat disease by inhibiting or modifying a pre-existing immune response). Growth factors, cytokines, and monoclonal antibodies intended to mobilize, stimulate, decrease or otherwise alter the production of hematopoietic cells in vivo 1http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm133463.htm CDRH Center for Devices and
Radiologic Health: FDA's Center for Devices and Radiological Health
(CDRH) is responsible for regulating firms who manufacture, repackage, relabel,
and/or import medical devices sold in the United States. In addition, CDRH
regulates radiation-emitting electronic products (medical and non-medical) such
as lasers, x-ray systems, ultrasound equipment, microwave ovens and color
televisions. http://www.fda.gov/AboutFDA/CentersOffices/CDRH/default.htm
cGMP: current Good
Manufacturing Practice: Bioprocessing children in research: Guidelines on involving human subjects, including,
but not limited to, clinical trials, supported or conducted by the NIH. NIH
Policy and Guidelines on the inclusion of children as participants in research
involving human subjects, NIH, US Mar. 8, 1998 http://grants1.nih.gov/grants/guide/notice-files/not98-024.html CLIA Clinical Laboratory
Improvement Amendments: Regulates all laboratory
testing (except research) performed on humans in the U.S. Part of the Centers
for Medicare and Medicaid Services (CMS). . http://www.cms.hhs.gov/clia/ Clinical Research Policy Analysis and Coordination: CRPAC: The Re-engineering the Clinical Research Enterprise
Roadmap set of initiatives is also addressing the difficulties clinical
researchers confront in satisfying the multiple requirements of diverse
regulatory and policy agencies. Clinical researchers must understand and fulfill
these varying requirements that often overlap and may even contradict one
another. NIH aims to take a leadership role in working with other agencies,
institutional review boards, and other organizations to develop better processes
and to standardize requirements for reporting adverse events, human subjects
protections, privacy and conflict-of-interest policies, and standards for
electronic data submission. Harmonizing policies and reporting requirements will
help minimize unnecessary burdens that slow research, while at the same time
enhancing patient protections. combination products: Include (1) A product comprised of two or more
regulated components, i.e., drug/device, biologic/device, drug/biologic, or
drug/device/biologic, that are physically, chemically, or otherwise combined or
mixed and produced as a single entity; Combination Drug Diagnostics: Fueling Growth of Personalized Medicine Insight Pharma Reports 2010 Committee on Human
Medicines: The MHRA was set up in April 2003 from a merger of
the Medicines Control Agency and the Medical Devices Agency. The MHRA is the
government agency which is responsible for ensuring that medicines and medical
devices work, and are acceptably safe. The MHRA is an executive agency of the
Department of Health. http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=301 common technical document: The
agreement to assemble all the Quality, Safety and Efficacy information in a
common format (called CTD - Common Technical Document ) has revolutionised the
regulatory review processes, led to harmonised electronic submission that, in
turn, enabled implementation of good review practices. For industries, it has
eliminated the need to reformat the information for submission to the different
ICH regulatory authorities. International Conference on Harmonisation http://www.ich.org/products/ctd.html comparability regulatory What do Regulatory Agencies Really Expect for Comparability? DVD May 26, 2010 compassionate use: See expanded access cosmeceuticals: While the Food, Drug, and Cosmetic Act does not recognize the term "cosmeceutical," the cosmetic industry uses this word to refer to cosmetic products that have medicinal or drug-like benefits. The Food, Drug, and Cosmetic Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body. While drugs are subject to a review and approval process by FDA, cosmetics are not approved by FDA prior to sale. If a product has drug properties, it must be approved as a drug. FDA, Cosmetics 2009 http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm127064.htm drug: Any substance which when absorbed into a living
organism may modify one or more of its functions. The term is generally accepted
for a substance taken for a therapeutic purpose, but is also commonly used
for abused substances. Synonymous with medicine, pharmaceutical. IUPAC
Compendium A drug is any substance
presented for treating, curing or preventing disease in human beings or in
animals. A drug may also be used for making a medical diagnosis or for
restoring, correcting, or modifying physiological functions (e.g., the
contraceptive pill). IUPAC Medicinal Chemistry http://www.chem.qmul.ac.uk/iupac/medchem/ah.html Should be considered
synonymous with investigational (medicinal) product, medicinal product and
pharmaceutical (including vaccines and other biological products). E15
terminology in Pharmacogenomics, ICH Draft 2 (Revision 2), 2008 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129296.pdf Narrower terms: specialty
pharmaceuticals. Compare biologics. Related terms: CDER, FDA. In
the US biologics and drugs are regulated by different Centers at
the FDA. drug safety: Drug safety &
pharmacovigilance CDER [FDA] evaluates the
safety profiles of drugs available to American consumers using a variety of
tools and disciplines throughout the life cycle of the drugs. We maintain a
system of postmarketing surveillance and risk assessment programs to identify
adverse events that did not appear during the drug development process. We learn
about adverse events through required reporting by companies and through
voluntary reports submitted to FDA’s MedWatch program, which together total
more than 250,000 reports per year. Staff in the Office of Drug Safety use this
information to identify drug safety concerns and recommend actions to improve
product safety and protect the public health. Activities include updating
drug labeling, providing more information to the community, implementing or
revising a risk management program, and, on rare occasions, reevaluating
approval or marketing decisions. Office of Drug Safety, CDER, FDA http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm106491.htm efficacy: Pharmaceutical biology EMEA: European Agency for the Evaluation of Medicinal
Products http://www.emea.eu.int/ expanded access: Expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial. They also permit expanded access for large groups of patients who do not have other treatment options available, once more is known about the safety and potential effectiveness of a drug from ongoing or completed clinical trials. FDA Access to Investigational drugs outside a clinical trials http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm exploratory
IND: Exploratory IND studies, which usually involve very
limited human exposure and have no therapeutic intent, can serve a number of
useful goals. For example, an exploratory IND study can help sponsors:
Gain an understanding of the relationship between a specific mechanism of action
and the treatment of a disease, Provide important information on
pharmacokinetics, including, for example, biodistribution of a candidate drug,
Select the most promising lead product from a group of candidates[5] designed to interact with a particular therapeutic
target in humans, Explore a product’s biodistribution characteristics using
various imaging technologies. FDA, CDER, Draft Guidance for Industry,
Investigators and Reviewers, Exploratory IND Studies, 2005 http://www.fda.gov/cder/guidance/6384dft.htm#_Toc100638010 FDA: Food and Drug Administration, US regulatory agency http://www.fda.gov/ FDA compliance: FDA compliance references http://www.fda.gov/ora/compliance_ref/default.htm FDA Drug Development and Review definitions: 2010 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm176522.htm FDA -- microarrays - regulating: The Food and Drug Administration (FDA) must balance the interests of the public for thorough review of new products for safety and efficacy, against the interests of the industry for a low cost, expedited process of regulatory approval. But all too often the process can place a significant drain on the resources of a company, particularly smaller companies that are introducing new products or innovative technology. It is actually in the interest of all parties to meet each of these requirements. Patients also have an interest in expedited review of new drugs, devices and diagnostics. Companies welcome a regulatory regime that ensures safety and thus public confidence in their products. And it is in nobody’s interest to have a company bankrupt itself just as it is trying to bring an innovative drug or technology to market. The FDA, however, is faced with extraordinary challenges, not only in terms of increased workload of conventional products, but also in trying to re- define regulatory procedures that are appropriate for technologies that take an entirely different approach to diagnostics and treatment, including microarrays, genotyping and pharmacogenomics. How the genomic revolution affects FDA Regulation, CHI GenomeLink 5.1 http://www.chidb.com/newsarticles/issue5-1.ASP FDA
Regulatory Procedures Manual: Glossary http://www.fda.gov/ora/compliance_ref/rpm/pdf/ch11.pdf 2004, 25 pages FDAMA: The Food and Drug Modernization Act of 1997
reauthorized the collection of user fees by the FDA and amended the Federal
Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the
regulation of food, drugs, devices, and biological products, and facilitate the
development and evaluation of new drugs and biologics designed to treat serious
and life - threatening illnesses. Tufts Center for the Study of Drug
Development, Glossary, 2007 http://csdd.tufts.edu/InfoServices/Glossary.asp FDA drug approvals: http://www.centerwatch.com/patient/drugs/drugls01.html 1995 - present fast- track: Speeding the development and availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or have advantages over existing treatments. The Food and Drug Administration (FDA) has developed three distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track. Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them. ... Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm follow ons: http://www.biotechnologyhealthcare.com/journal/fulltext/1/2/BH0102020.pdf http://www.boinetpopulation.bio.org/ip/newsletter/RIPLNewsletter.Issue5.pdf GCP Good Clinical Practice: At its core, Good Clinical Practice (GCP) is a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research. It is important to remember that much of the practical standards used in the conduct of clinical trials are "best practices" derived from regulations, guidances, and industry standards and practices and not all found in black and white in the regulations. Given the disparity between the detailed nature of clinical trial processes and tasks and the general GCP requirements and standards under which they occur, it is not surprising that interpreting and implementing GCP standards continue to represent challenges for the pharmaceutical, biotechnology, and medical device industries. Barnett International, Good Clinical Practice: A Question & Answer Reference Guide, 2012 http://www.barnettinternational.com/EducationalServices_Publication.aspx?p=10067&id=115409 Good Clinical Practice in FDA Regulated
Clinical Trials http://www.fda.gov/oc/gcp/default.htm generic drugs: Drugs whose drug name is not protected by a
trademark. They may be manufactured by several companies. MeSH, 1992 GLP
Good Laboratory Practice: Good
Laboratory Practices: Guide to Compliance, provides clear
recommendations for performing preclinical laboratory studies according
to 21CFR58 and the OECD Principles of Good Laboratory Practice. The
Guide includes templates for SOPs and other forms that can be copied and
used directly in the laboratory, including a full set of GLP inspection
sheets. http://www. GMP Good Manufacturing
Practice: Bioprocessing guidance documents:
Documents prepared for FDA staff, applicants/
sponsors, and the public that describe the agency`s interpretation of or policy
on a regulatory issue. Guidance documents include, but are not limited to,
documents that relate to: The design, production, labeling, promotion,
manufacturing, and testing of regulated products; the processing, content, and
evaluation or approval of submissions; and inspection and enforcement policies.
Guidance documents do not include: Documents relating to internal FDA
procedures, agency reports, general information documents provided to consumers
or health professionals, speeches, journal articles and editorials, media
interviews, press materials, warning letters, memoranda of understanding, or
other communications directed to individual persons or firms. ...Guidance
documents do not establish legally enforceable rights or responsibilities. They
do not legally bind the public or FDA. FDA, CDRH, Administrative Practices
and Procedures, 21CFR10.115, April 2004 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.115 GxP: GxP: A general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries. http://en.wikipedia.org/wiki/GxP accessed Jan 11, 2011 Narrower terms: GCP, GLP, GMP harmonization
of pharmaceuticals regulations: See ICH International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use HIPAA Health Insurance
Portability and Accounting Act: Health & Human
Services, US http://www.hhs.gov/ocr/hipaa/ home brew: Reagents or the combination of reagents
made in a laboratory, or purchased reagents used by that laboratory for clinical
tests and not for sale to other laboratories. Neal Holtzman, Michael Watson
"Promoting Safe and Effective Genetic Testing in the United States: Final
Report" glossary, 1997, last updated 2004 http://www.genome.gov/10002399 ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. ICH Homepage http://www.ich.org/home.html IND
Investigational New Drug Application: A request for Food and Drug
Administration (FDA) authorization to administer an investigational drug to
humans. Such authorization must be secured prior to interstate shipment and
administration of any new drug that is not the subject of an approved new drug
application. CDER, FDA, US "Information for Sponsor- Investigators
Submitting Investigational New Drug Applications (INDs) 2001 http://www.fda.gov/cder/forms/1571-1572-help.html IND reports http://www.fda.gov/cder/rdmt/default.htm informed consent: Guide to Informed Consent,
Guidance for Institutional Review Boards and Clinical Investigators IRB
Institutional Review Board: A specially constituted
review body established or designated by an entity to protect the welfare of
human subjects recruited to participate in biomedical or behavioral research
[Federal Policy §§___.102(g), ___.108, ___.109]. Institutional Review Board
glossary http://www.hhs.gov/ohrp/archive/irb/irb_glossary.htm Laboratory Developed Tests http://www.clinical-labs.org/documents/20101215_AvalereSummaryLDT_v2.pdf
See also Analyte Specific Reagents me too drug: A compound that is structurally very similar to
already known drugs, with only minor pharmacological differences. IUPAC
Medicinal Chemistry Related terms: follow-ons
Drug discovery& development analogue based drug
discovery medical device: Medical devices range from simple tongue depressors
and bedpans to complex programmable pacemakers with micro- chip technology and
laser surgical devices. In addition, medical devices include in vitro
diagnostic products, such as general purpose lab equipment, reagents, and test
kits, which may include monoclonal antibody technology. Certain
electronic radiation emitting products with medical application and claims meet the
definition of medical device. Examples include diagnostic ultrasound products,
x-ray machines and medical lasers. If a product is labeled, promoted or used in
a manner that meets the following definition in section 201(h) of the Federal
Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing
and postmarketing regulatory controls. A device is: "an instrument,
apparatus, implement, machine, contrivance, implant, in vitro reagent, or
other similar or related article, including a component part, or accessory which
is: recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, or intended to affect the
structure or any function of the body of man or other animals, and which does
not achieve any of it's primary intended purposes through chemical action within
or on the body of man or other animals and which is not dependent upon being
metabolized for the achievement of any of its primary intended purposes."
FDA, Center for Devices and Radiological Health, US "Is the product a
medical device?" 1998 http://www.fda.gov/cdrh/devadvice/312.html#contents Medicines Control Agency: The executive agency of the Department of Health
safeguarding public health by ensuring that all medicines on the UK market meet
appropriate standards of safety, quality and efficacy. http://www.mca.gov.uk/ MedWatch: FDA Safety Information and Adverse Event Reporting
Program http://www.fda.gov/medwatch/index.html minorities- research: Women and minorities as participants in
research involving human subjects - Policy implementation stage, Office of
Extramural Research, NIH, 2003 http://grants1.nih.gov/grants/funding/women_min/women_min.htm Minorities, race and
Genetics: Human Genome Project Information, DOE, US http://www.ornl.gov/TechResources/Human_Genome/elsi/minorities.html NCE New
Chemical Entity: A compound not previously described in the
literature. [IUPAC Medicinal Chemistry] Any new molecular compound
not previously approved for human use, excluding diagnostic agents, vaccines and
other biologic compounds not approved by the FDA's Centers for Drug Evaluation
and Research (CDER). Also excluded are new salts, esters and dosage forms of
previously approved compounds. Tufts Center for the Study of Drug
Development, Glossary, 2007 http://csdd.tufts.edu/InfoServices/Glossary.asp NDA New
Drug Application: CDER (FDA) New and generic drug approvals interim
index http://www.fda.gov/cder/approval/index.htm NDA New Drug Approvals, New
Drug Applications reports http://www.fda.gov/cder/rdmt/default.htm NME New Molecular Entity: An active ingredient that has never before
been marketed in the United States in any form. Drugs@FDA
Glossary of terms http://www.fda.gov/Drugs/informationondrugs/ucm079436.htm non-prescription drugs: Drugs that can be sold legally without a
prescription. MeSH, 1974 OTC drugs: Over the counter
drugs. See also non-prescription drugs off label: The use of an FDA- approved drug or device for a
purpose other than that intended by the manufacturer and described on the label.
FDA only approves drugs or devices for their intended use as described on the
label. Neal Holtzman, Michael Watson "Promoting Safe and Effective Genetic
Testing in the United States: Final Report" glossary, 1997 http://www.nhgri.nih.gov/ELSI/TFGT_final/glossary.html orphan drug: Drugs developed for rare diseases and conditions
which, in the U.S., affect fewer than 200,000 people or, in the European Union,
affect 5 or fewer per 10,000 people. Because sales of orphan drugs are likely to
be small compared to their development costs, pharmaceutical companies are
awarded exclusive rights to market these medicines for a period of time as an
incentive to develop them. Tufts Center for the Study of Drug
Development, Glossary, 2007 http://csdd.tufts.edu/InfoServices/Glossary.asp orphan products: The Orphan Drug Act (ODA) provides for granting special status to a
product /indication combination upon request of a sponsor, and if the
product/indication combination meets certain criteria. This status is referred
to as orphan designation. Orphan designation qualifies the sponsor of the
product for the tax credit and marketing exclusivity incentives of the ODA. FDA,
US Orphan Product Designation, 2001 http://www.fda.gov/orphan/designat/index.htm increasing
frequency for post-approval Another effort to shorten
the FDA review process. Under this act, fees the FDA collected from drug
developers between 1993 and 1997 were to be used to shorten the timelines needed
for evaluating certain drug applications, in part through the hiring of more
reviewers. At the same time, the FDA committed to a set of goals for
streamlining the review process. The original PDUFA act expires on September 30,
1997, but the FDA Modernization Act of 1997 extended the act through September
30, 2002. pharmacovigilance: Drug safety Phase
IV Planned post-marketing studies of diagnostic,
therapeutic, or prophylactic drugs, devices, or techniques that have been
approved for general sale. These studies are often conducted to obtain
additional data about the safety and efficacy of a product. This concept
includes phase IV studies conducted in both the U.S. and in other countries.
MeSH Clinical trials, Phase IV as topic post approval drug safety: Drug safety &
pharmacovigilance predicate rules: This document provides guidance to persons who, in
fulfillment of a requirement in a statute or another part of FDA's regulations
to maintain records or submit information to FDA,3 have chosen to maintain the records or submit
designated information electronically and, as a result, have become subject to
part 11. Part 11 applies to records in electronic form that are created,
modified, maintained, archived, retrieved, or transmitted under any records
requirements set forth in Agency regulations. Part 11 also applies to electronic
records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act
(the Act) and the Public Health Service Act (the PHS Act), even if such records
are not specifically identified in Agency regulations (§ 11.1). The underlying
requirements set forth in the Act, PHS Act, and FDA regulations (other than part
11) are referred to in this guidance document as predicate rules. CDER, FDA,
Guidance for Industry, Electronic Records, Electronic Signatures, 2003 http://www.fda.gov/cder/guidance/5667fnl.htm premarket approval PMA: The Medical Device Amendments of 1976 to the
Federal Food, Drug, and Cosmetic Act (the act) established three regulatory
classes for medical devices. The three classes are based on the degree of
control necessary to assure that the various types of devices are safe and
effective. The most regulated devices are in Class III. The amendments define a
Class III device as one that supports or sustains human life or is of
substantial importance in preventing impairment of human health or presents a
potential, unreasonable risk of illness or injury. [Information on
Premarket Approval Applications, FDA, CDRH, 2001] http://www.fda.gov/cdrh/pmapage.html Related term medical device prescription drugs: Drugs whose use must be authorized by a
professional health provider. priority review: A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months. http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm Related terms: accelerated approval, fast track proprietary drug,
proprietary name: Trademarked,
brand name. Compare generic. protocol: The formal design or plan of an experiment or
research activity; specifically, the plan submitted to an IRB for review and to
an agency for research support. The protocol includes a description of the
research design or methodology to be employed, the eligibility requirements for
prospective subjects and controls, the treatment regimen(s), and the proposed
methods of analysis that will be performed on the collected data. [IRB] PSUR Periodic Safety Update
Report: Drug safety,
pharmacovigilance and toxicology public policy and
biotechnology: US President's Council on Bioethics http://www.bioethics.gov/topics/biotech_index.html regulated information systems: Regulatory demands are changing the way information systems will be designed and implemented in the life sciences industry. With the introduction of 21 CFR Part 11 and HIPAA in the U.S., and new requirements from EMEA, CEOs and CIOs are paying much more attention to security, access and control issues. These requirements are causing the development of a new information systems market - the regulated systems market. The regulated systems market requires the use of information systems that can protect personal health information and ensure that every document and data set has been secured, audited for changes, and authenticated with respect to signature authorities. New Regulatory Requirements Are Changing the Way Pharmaceutical Companies Do Business and Creating a New Market for Informatics Systems: An Interview with Bernard P. Wess, Jr., of PERSEID, CHI's GenomeLInk 24.2 http://www.chidb.com/newsarticles/issue24_2.asp regulatory agencies: See
EMEA, FDA, ICH. Related term: harmonization
regulatory compliance drug diagnostic co-development: Molecular Diagnostics regulatory
science: The NIH and the U. S. Food
and Drug Administration (FDA) have formed an interagency partnership to foster
regulatory science, a specialized and inter-disciplinary area of biomedical
research that serves to generate new knowledge and tools for assessing
experimental therapies, preventives, and diagnostics. A key goal of this new
Regulatory Science program is to accelerate the development and use of new
tools, standards and approaches to efficiently develop products and to more
effectively evaluate product safety, efficacy and quality. Regulatory Science,
NIH Common Fund http://commonfund.nih.gov/regulatoryscience/overview.aspx
REMS Risk Evaluation and Mitigation Strategy : Drug
Safety
screening IND: In general, CDER policy has been to encourage separate INDs for different molecules and dosage forms. However, in the early phase of drug development, before the developmental path is clear, exploratory studies may be conducted on a number of closely related drugs to choose the preferred compound or formulation. These studies may be best and most efficiently conducted under a single IND, referred to as a screening IND. CDER, FDA, Manual of policies and procedures MAPP 6030.4, 2002 http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082026.pdf specified biotechnology products: Was well characterized biotechnology product. third party review: Another example of the FDA
making use of external resources to ensure quality submission and flexibility in
its approval process. In the pilot program for third party review, we obtained
the assistance of the State of California Department of Health. The FDA provided
them with a guidance document, clearly outlining the objectives, the type of
information we are interested in, the process of review and the key points to
look for when considering an application. Based on those guidelines, the
Department of Health reviewed one 501(k) case and concluded that it was a
substantial equivalent to a marketed product. The FDA then had 30 days to review
it. Actual review time was only 15 days. The role of the FDA was that of quality
control, essentially to oversee the procedure and make sure the third party did
everything right. The procedure has worked out fairly well, but the actual
number of submissions to this program was low. In 1999, there were only two. To
date, the total is only eleven. Joseph Hackett unapproved
drugs, access to: See expanded access well characterized biotechnology products See specified biotechnology products women and minorities-
research: Women and minorities as participants in research
involving human subjects - Policy implementation stage, Office of Extramural
Research, NIH, 2003 http://grants1.nih.gov/grants/funding/women_min/women_min.htm Bibliography
How to look for other unfamiliar terms IUPAC definitions are reprinted with the permission of the International Union of Pure and Applied Chemistry. |
Contact
| Privacy Statement |
Alphabetical
Glossary List | Tips & glossary
FAQs | Site Map
