Flashcards
Reg affairs
Flashcards do conjunto (42)
- 1What are the branches of the federal government?1. Executive branch
2. Legislative branch
3. Judicial branch - 2Who creates agencies?Congress
- 3Who oversees agencies?the president
- 4Which agency does the FDA bring its case to for criminal prosecution?The Department of Justice
- 5What type of enforcement activities does the FDA have?1. Administrative
2. Judicial - 6What are the FDA's administrative actions?1. List of inspectional observations (Form 483)
2. Warning letters
3. Adverse publicity
4. Debarment
5. Suspension or withdrawal of product approvals
6. license revocations
7. disqualification of clinical investigators - 7What are the FDA's judicial actions?Civil action: seizure, injunction, civil monetary penalties
Criminal action: criminal prosecution - 8What is the Pure Food and Drug Act of 1906?- in response to Upton Sinclair's book The Jungle revealing the filth in the meat packing industry
- first Food and Drug law
- prohibited interstate commerce of misbranded and adulterated foods, drinks, and drugs (did not include cosmetics)
- did not prohibit false health claims - 9What is the Sherley Amendment of 1912?- prohibited false and fraudulent label claims of therapeutic effectiveness
- had to prove deliberate fraud by the promoter
- only covered labels, not advertising - 10What is the Federal Food, Drug and Cosmetic Act of 1938?- in response to the "Miracle Drug" tragedy of 1937 (Sulfanilamide Elixir was manufactured with diethylene glycol without safety testing; 107 people died, mostly children)
- safety testing now required
- authorized manufacturing site inspections
- added injunctions to previous legal authority of seizure and prosecution - 11What is the Federal Food, Drug and Cosmetic Act of 1938?Labeling must include:
1. Manufacturer, distributor or packer's name
2. statement of "net contents"
3. common drug name
4. list of all active ingredients
5. adequate directions for use
6. adequate warnings - 12What are the Kefauver-Harris Drug Amendments of 1962?- as a result of Thalidomide, a new sleeping pill found to cause birth defects in thousands of babies born in Western Europe
- requires safety and efficacy testing prior to marketing
- requires registration and inspection of manufacturing facilities
- requires compliance to Good Manufacturing Practices (cGMP)
- required informed consents for clinical trial subjects - 13What is the Durham-Humphrey Act of 1951?Written prescriptions and physician monitoring required for some medications
- 14What is the Medical Device Amendments Act of 1976?established classifications, safety, and effectiveness of medical devices
- 15What is the Orphan Drug Act of 1983?- tax breaks for drugs that aren't economically worthwhile to pursue if drug works for limited population
- 16What is the Hatch-Waxman Act of 1984?- must show bioequivalence
- no safety or effectiveness testing required - 17What is the Prescription Drug User Fee Act (PDUFA) of 1992?- adds mandatory monetary resources from filers for FDA review process
- 18What is the Food and Drug Administration Modernization Act (FDAMA) of 1997?- established and expedited review process
- streamlined regulatory review procedures - 19What are the 5 centers of the FDA?Center for Drug Evaluation and Research (CDER)
Center for Device and Radiologic Health (CDRH)
Center for Biologics Evaluation and Research (CBER)
Center for Food Safety and Applied Nutrition (CFSAN)
Center for Veterinary Medicine (CVM) - 20What are the 3 main types of violations?1. adulterated
2. misbranded
3. marketed without FDA approval - 21What does the FDA NOT regulate?- practice of medicine
- nursing
- pharmacy
- other health-related professions - 22Who is the FDA accountable to?- FDA is part of the executive branch: answerable to the Assistant Secretary for Health, Secretary of Health and Human Services, the Office of Management and Budget, the President
- also accountable to Congress - 23How are the centers structured?Offices-->Divisions-->Branches-->Teams
- 24What is the Office of Chief Counsel (OCC)?- part of the Department of Health and Human Services Office of General Counsel (NOT a part of the FDA)
- advices on the law and FDCA
- advises the Commissioner on the law/policy
- assesses whether the Agency will prevail - 25What kinds of regulations can the FDA issue?- interpretive: agency's views of what the statue means
- substantive: extends a provision of law and specifies what that provision requires; has the force and effect of law - 26What are the levels of a guidance document?- level 1: initial interpretation of statue or regulation; changes in interpretation that are more than minor in nature
- level 2: describes existing practices; minor changes in interpretation - 27What is the Food and Drug Administration Amendments Act (FDAAA) of 2007?- expanded FDA's power to require post-marketing studies and safety-related labeling changes
- supplement with the label change must be submitted within 30 days OR explain why a label change isn't warranted - 28What are Prior Approval Supplements (PAS)?- required for any change to the drug or manufacturing process, equipment or facilities
- 29What are Changes Being Effected (CBE)?- required for changes with only a moderate potential for an adverse effect on the drug's performance
- 2 categories: CBE-30 (company needs to wait 30 days after submitting supplement before starting distribution of product with changes), CBE-0 (company can distribute immediately once FDA receives supplement) - 30When is a CBE-30 required?- required for changes such as those involving container-closure systems not affecting its quality, or relaxation of an inspection criterion or deletion of a test to comply with an official compendium that is consistent with FDA statutory and regulatory requirements
- 31When is a CBE-0 used?- changes such as addition to a specification or changes in methods or controls to provide increased assurance that the drug will have the characteristics it claims to possess
- labeling changes that strengthen a contraindication, warning, precaution or adverse reaction, or strengthens dosage and administration information to ensure safe use - 32What are the 3 types of post-marketing reports?1. Prior Approval Supplements (PAS)
2. Changes Being Effected (CBE)
3. Annual Reports - 33What is included in an annual report?- minor changes in wording on the label
- deletion or reduction of an ingredient that only affects the product's color
- changes in a product's container or size without changes in the closure system - 34What are phase IV studies?- obtain additional safety and efficacy data
- detect new uses for abuse
- determine effectiveness for labeled indications under widespread use
- allows FDA to approve the drug while applicant completes additional safety and efficacy studies - 35What are the 3 main routes to securing market protection for new drug products?1. patent term extension periods
2. non-patent exclusivity (NCE) provisions for new chemical entities and approvals requiring new clinical studies
3. non-patent exclusivity for orphan drugs - 36What are the different market exclusivities?- orphan drug: 7 years
- new chemical entities (NCEs): 5 years - 37What is the Best Pharmaceuticals for Children Act?- patent terms, statutory exclusivities and orphan exclusivity are all eligible for 6 month extension if sponsor completes a pediatric study in response to a written request from FDA
- 38What are the requirements of an Abbreviated New Drug Application (ANDA)?- show proposed drug previously approved by FDA
- proof active ingredient is the same
- proof of the same route of administration, dosage, and strength
- proof of bioequivalence
- same labeling
- basic technical information required in NDA
- samples of product and proposed labeling
- patent certification informing FDA of patent status of reference drug - 39When is a suitability petition used?- for different active ingredient(s), routes of administration, dosage forms and strengths of generic drugs
- 40What is pharmacovigilance?- all post-approval scientific and data gathering activities related to detection, assessment, understanding and prevention of adverse events or any other product-related problems
- 41What are the different types of post-marketing reports?1. 15-day alert report
2. 15-day follow-up report
3. period adverse experience reports
4. field alerts
5. annual reports - 42What are Class 1 medical devices?- lowest level
- require general controls (must follow cGMPs during manufacturing)
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- FlashCards sobre Reg affairs, criado por bokchoi.helen em 18-10-2014.
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- bokchoi.helen
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