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You are here Biopharmaceuticals Glossary Homepage > Business > Clinical trials and Drug discovery & development > Regulatory Affairs
Regulatory Glossary & taxonomy
Drug
discovery term index
Ethics
Regulatory Affairs is a sub-category of
Drug discovery &
development
21 CFR Part 11, Electronic records, Electronic signatures: This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).2 https://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm 510K: Biomaterials & Medical Devices
accelerated approval:
The FDA
instituted its Accelerated Approval Program to allow for earlier approval of
drugs that treat serious conditions, and that fill an unmet medical need based
on a surrogate endpoint. A surrogate endpoint is a marker, such as a
laboratory measurement, radiographic image, physical sign or other measure that
is thought to predict clinical benefit, but is not itself a measure of clinical
benefit. The use of a surrogate endpoint can considerably shorten the time
required prior to receiving FDA approval. FDA Accelerated Approval
Program
http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm313768.htm
Advanced therapy medicinal products (ATMPs): medicines for human use that
are based on genes, tissues or cells.
They offer groundbreaking new opportunities for the treatment of disease
and injury.
ATMPs can be classified into three main types:
gene
therapy medicines: these
contain genes that lead to a therapeutic, prophylactic or diagnostic
effect. They work by inserting 'recombinant' genes into the body, usually
to treat a variety of diseases, including genetic disorders, cancer or
long-term diseases. A recombinant gene is a stretch of DNA that is created
in the laboratory, bringing together DNA from different sources; 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. CFR Title 21 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=864.4020 Wikipedia https://en.wikipedia.org/wiki/Analyte-specific_reagent See also Laboratory Developed Tests bioavailability, bioequivalence: Drug delivery See also therapeutic equivalency
biogenerics:
A biopharmaceutical or other biological product
... that has emerged from patent protection and can be manufactured by a party
other than the original developer using either identical or different
manufacturing processes, for FDA approval the product must be bioequivalent or comparable to the original innovative product.
https://medical-dictionary.thefreedictionary.com/Biogeneric
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 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/OfficeofMedicalProductsandTobacco/CBER/default.htm
CBER has undergone an internal restructuring.
The new CBER structure includes the Office of Blood Research and Review
(OBRR), the Office of Vaccines Research and Review (OVRR), and the Office
of Tissues and Advanced Therapies (OTAT, formerly known as the Office of
Cellular, Tissue and Gene Therapies, or OCTGT). The formation of
OTAT involves the transfer of OBRR’s Division of Hematology Clinical
Review and Division of Hematology Research and Review, along with
appropriate support staff, to OCTGT to constitute the new office.
The products now regulated by OTAT include all purified and recombinant
versions of therapeutic proteins for hematology. Antivenins have
also been transferred to OTAT. This new organizational structure
became effective on October 16, 2016.
FDA, CBER
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm525907.htm CDER Center for Drug Evaluation and Research: http://www.fda.gov/cder/ The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. 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. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs." https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/default.htm
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: A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to 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 [often referred to as a “single-entity” combination product]; 2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products [often referred to as a “co-packaged” combination product]; 3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose) [often referred to as a “cross-labeled” combination product]; or 4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect [another type of “cross-labeled” combination product]. FDA, Frequently asked questions aboout Combination Products https://www.fda.gov/combinationproducts/aboutcombinationproducts/ucm101496.htm#CP
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 compassionate use: See expanded access cosmeceuticals: The term "cosmeceutical" has no meaning under the law. While the Federal Food, Drug, and Cosmetic Act (FD&C 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. A product can be a drug, a cosmetic or both. The FD&C Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body, if a product makes such claims it will be regulated as a drug. Cosmetics are intended to beautify, promote attractiveness, alter appearance or cleanse; they are not approved by FDA for sale nor are they intended to effect structure or function of the body. 2017 https://www.fda.gov/Cosmetics/Labeling/Claims/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
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073162.pdf
EMEA: European Agency for the Evaluation of Medicinal Products now EMA: European Medicines Agency http://www.ema.europa.eu/ 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 https://www.fda.gov/ForPatients/Other/default.htm
exploratory
IND:
Exploratory IND studies
usually involve very limited human exposure and have no therapeutic or
diagnostic intent. Such studies can serve a number of useful goals. For example,
an exploratory IND study can help sponsors • Determine whether a mechanism of
action defined in experimental systems can also be observed in humans (e.g., a
binding property or inhibition of an enzyme)
•
Provide important information on pharmacokinetics (PK) • Select the most
promising lead product from a group of candidates designed to interact with a
particular therapeutic target in humans, based on PK or pharmacodynamic (PD)
properties.
FDA, CDER, Draft Guidance for Industry,
Investigators and Reviewers, Exploratory IND Studies, 2006
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078933.pdf
Related term: Phase zero,
Phase 0 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. https://www.fda.gov/forpatients/approvals/fast/ucm405399.htm
FDA:
Food and Drug Administration, US regulatory agency
http://www.fda.gov/
FDA Compliance Manuals https://www.fda.gov/ICECI/ComplianceManuals/default.htm FDA Drug Development and Review definitions: 2010 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm176522.htm FDA Regulatory Procedures Manual: a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters. https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm Regulatory Procedures Manual Glossary https://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074290.pdf
FDAMA:
The Food and Drug Administration Modernization Act (FDAMA), enacted Nov. 21,
1997, amended the Federal Food, Drug, and Cosmetic Act relating to the
regulation of food, drugs, devices, and biological products. With the passage of
FDAMA, Congress enhanced FDA's mission in ways that recognized the Agency would
be operating in a 21st century characterized by increasing technological, trade
and public health complexities.
FDA drug approvals:
http://www.centerwatch.com/patient/drugs/drugls01.html 1995 - present follow ons: The
development of so-called ‘me-too’, or ‘follow-on’, drugs by the
pharmaceutical industry has been viewed by some as duplicative and wasteful,
while others have argued that these drugs often provide needed therapeutic
options and inject some price competition into the marketplace. This study
examines data on the trends in the speed with which competitive entry has
occurred in the pharmaceutical marketplace and the competitive nature of the
industry’s development of these drugs. The Economics of Follow-on Drug
Research and Development
Trends in
Entry Rates and the Timing of Development Joseph A. DiMasi and Cherie Paquette
Pharmacoeconomics 2004; 22 Suppl. 2: 1-14 1170-7690/04/0002-0001
http://www.who.int/intellectualproperty/submissions/Submission_DiMasi.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,
Good Clinical Practice FDA
The Office of Good Clinical Practice is the focal point within FDA for Good
Clinical Practice (GCP) and Human Subject Protection (HSP) issues arising in
human research trials regulated by FDA.
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018191.htm
GCP FDA Adherence to the principles of good
clinical practices (GCPs), including adequate human subject protection
(HSP) is universally recognized as a critical requirement to the conduct
of research involving human subjects. Many countries have adopted GCP
principles as laws and/or regulations. The Food and Drug Administration’s
(FDA’s) regulations for the conduct of clinical trials, which have been in
effect since the 1970s, address both GCP and HSP. These FDA regulations
and guidance documents are accessible from this site. International GCP
guidance documents on which FDA has collaborated and that have been
adopted as official FDA guidance are also be found here. Finally, this
site includes links to other sites relevant to the conduct of clinical
trials, both nationally and internationally. https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
generic drugs:
Drugs whose drug name is not protected by a
trademark. They may be manufactured by several companies. MeSH, 1992
Generic drug products are defined as drug
products that are identical to an innovative (brand-name) drug which is
the subject of an approved NDA with regard to active ingredient(s), route
of administration, dosage form, strength, and conditions of use. Since
ANDA submissions for generic applications do not require lengthy clinical
evaluation of the generic drugs under investigation (see Table
1), the price of generics are usually
much lower than that of the originals. On average, it is about 20% of the
price of the brand-name originals. In 1984, the United States Food and
Drug Administration (FDA) was authorized to approve generic drug products
under the Drug Price Competition and Patent Term Restoration Act. The
purpose is to make less expensive, safe, and equally efficacious generics
available to general public after the expiration of patent protection of
expensive brand-name drugs. For approval of generic drug products, the FDA
requires that evidence of average bioequivalence in drug absorption be
provided through the conduct of bioavailability and bioequivalence
studies. Bioequivalence assessment is considered as a surrogate for
clinical evaluation of the therapeutic equivalence of drug products.
Bioavailability and Bioequivalence in Drug Development. Wiley Interdiscip
Rev Comput Stat. 2014;6(4):304-312.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4157693/
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.
guidance documents
FDA:
Guidance
documents represent FDA's current thinking on a topic. They do not create
or confer any
rights for or on any person and do not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements
of the applicable statutes and regulations.
http://www.fda.gov/regulatoryinformation/guidances/
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
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: 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:
Current Federal law requires that a
drug be the subject of an approved marketing application before it is
transported or distributed across state lines. Because a sponsor will probably
want to ship the investigational drug to clinical investigators in many states,
it must seek an exemption from that legal requirement. The IND is the means
through which the sponsor technically obtains this exemption from the FDA.
http://www.fda.gov/%20Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm
Narrower terms: exploratory
IND, screening IND
informed consent: Guide to Informed Consent,
Guidance for Institutional Review Boards and Clinical Investigators FDA,
http://www.fda.gov/oc/ohrt/irbs/informedconsent.html
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
https://www.hhs.gov/ohrp/sachrp-committee/recommendations/2011-january-24-letter-attachment-a/index.html
Institutional Review Boards http://www.hhs.gov/ohrp/assurances/irb/index.html
Laboratory Developed Tests:
The Coverage and Analysis Group at the Centers
for Medicare & Medicaid Services (CMS) requested from The Technology
Assessment Program (TAP) at the Agency for Healthcare Research and Quality
(AHRQ) a horizon scan to summarize the available scientific evidence on the
quality of laboratory-developed ("home brew" or "in-house")
molecular tests, which are currently not actively regulated by the U.S. Food and
Drug Administration (FDA). CMS has concerns about the
quality of laboratory-developed tests and the validation currently being
performed on these tests . AHRQ assigned this report to the following Evidence-based Practice Center (EPC):
ECRI EPC (Contract Number: 290 2007 10063 I). To help CMS to address its
concerns, this horizon scan is intended to: 1) identify types of
laboratory-developed molecular tests (LDMTs) currently available for conditions
relevant to the Medicare over-65-year-old population, 2) identify the
methodologies and the processes that have been developed for the assessment of
analytical and clinical performance of molecular tests, 3) summarize the role of
Federal agencies in regulating LDMTs, and 4) identify the quality standards that
have been developed for molecular tests by regulatory bodies, the industry, and
the medical community.
http://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=72&bc=BAAgAAAAAAAA&
See also Analyte Specific Reagents
MedWatch: FDA Safety Information and Adverse Event Reporting
Program
http://www.fda.gov/medwatch/index.html
Medicines and Healthcare
Regulatory Authority
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
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
NCE New
Chemical Entity: A compound not previously described in the
literature. IUPAC Medicinal Chemistry
NDA New
Drug Application:
For
decades, the regulation and control of new drugs in the United States has been
based on the New Drug Application (NDA). Since 1938, every new drug has been the
subject of an approved NDA before U.S. commercialization. The NDA
application is the vehicle through which drug sponsors formally propose that the
FDA approve a new pharmaceutical for sale and marketing in the U.S. The
data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become
part of the NDA.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ Wikipedia http://en.wikipedia.org/wiki/New_Drug_Application
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 Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act. FDA New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/default.htm
non-prescription drugs:
Drugs that can be sold legally without a
prescription. MeSH, 1974
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
openFDA:
The openFDA project was created to provide easy access to public data, to create
a new level of openness and accountability, to ensure the privacy and security
of public FDA data, and ultimately to educate the public and save lives. The
concept was to index high-value, high priority and scalable public-access data,
format and document that data in developer and consumer-friendly standards, and
make that data available via a public-access portal that enables developers to
quickly and easily use it in applications.
.
http://open.fda.gov/
orphan designation:
Committee for Orphan
Medicinal Products COMP, EMA, European Union
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp
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
http://www.fda.gov/orphan/designat/index.htm
incrasin
frequency for post-approval
PDUFA Prescription Drug User Fee Act (1992):
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, pharmacovigilance, post marketing surveillance
predicate rules: A
predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic
Act, the Public Health Service Act, or any FDA regulation other than Part 11. Wikipedia
accessed Nov 5 2013
http://en.wikipedia.org/wiki/Title_21_CFR_Part_11
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. https://www.fda.gov/forpatients/approvals/fast/ucm405405.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, post marketing surveillance
regulatory agencies: See
EMA, FDA, ICH, MHRA. Related term: harmonization
regulatory compliance drug diagnostic co-development: Molecular Diagnostics Regulatory Intelligence (RI): the act of gathering and analyzing regulatory information for impact or changes in laws, regulations, directives, guidance documents, etc. There is more to RI than the black and white of regulations or guidance documents; there are many colors of possible interpretations found through researching regulatory precedents, industry practices, Health Authority (HA) opinions, competitor information, etc RAPS Learning Portal http://learningportal.raps.org/products/1496/regulatory-intelligence-101-what-where-why-and-how-to-present-back-to-the-team-on-demand-webcast REMS Risk Evaluation and Mitigation Strategy: Drug safety, pharmacovigilance, post marketing surveillance safe harbor:
In patent law,
the research exemption or safe harbor exemption is an
exemption to the rights conferred by patents, which is especially relevant
to drugs.
According to this exemption, despite the patent rights, performing research and
tests for preparing regulatory approval, for instance by the FDA in
the United
States, does not constitute infringement for
a limited term before the end of patent
term.[1] This
exemption allows generic manufacturers to prepare generic
drugs in advance of the patent expiration.
third party review: The Accredited Persons Program was created by the FDA Modernization Act of 1997 (FDAMA), based on an FDA pilot. The purpose of the program is to improve the efficiency and timeliness of FDA's 510(k) process, the process by which most medical devices receive marketing clearance in the United States. Under the program, FDA has accredited third parties (Accredited Persons) that are authorized to conduct the primary review of 510(k)s for eligible devices. Persons who are required to submit 510(k)s for these devices may elect to contract with an Accredited Person and submit a 510(k) directly to the Accredited Person. The Accredited Person conducts the primary review of the 510(k), then forwards its review, recommendation, and the 510(k) to FDA. By law, FDA must issue a final determination within 30 days after receiving the recommendation of an Accredited Person. 510(k) submitters who do not wish to use an Accredited Person may submit their 510(k)s directly to FDA. https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/thirdparyreview/default.htm
unapproved
drugs, access to: See expanded access women and minorities- human subjects research: NIH https://grants.nih.gov/grants/funding/women_min/women_min.htm Regulatory
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