Drug approval Flashcards
What law Prohibited mislabeling and adulteration of drugs?
Pure Food & Drug Act: 1906
What law Prohibited false or fraudulent advertising claims?
What was Harrison Narcotic Act: 1914?
What was the Food, Drug, & Cosmetic Act: 1938?
Required that new drugs be safe as well as pure (no proof of efficacy). Enforcement by FDA
What law was Vested in the FDA the power to determine which products could be sold without prescription?
Durham-Humphrey Act: 1952
What did the Kefauver-Harris Amendments (1962) to the Food, Drug, & Cosmetic Act cause?
Required proof of efficacy as well as safety for new drugs and for drugs released since 1938;
established guidelines for reporting of information about adverse reactions, clinical testing, and advertising of new drugs
What was the effect of Comprehensive Drug Abuse Prevention & Control Act: 1970?
Outlined strict controls for habit-forming drugs; established drug schedules and programs to prevent and treat drug addiction
What was the effect of Orphan Drug Amendments: 1983?
Provided incentives for development of drugs that treat rare diseases (<200,000 in USA)
What was the effect of Drug Price Competition & Patent Restoration Act: 1984?
Abbreviated NDAs for generic drugs (bioequivalence data).
Patent life extended to account for FDA review process ( max ≤ 5 extra years or 14 years post-NDA approval
What was the law that caused the effect of Manufacturers pay user fees for certain NDAs?
Where was the effect Dietary Supplement Health and Education Act: 1994?
Established standards for dietary supplements; prohibited full FDA review as drugs.
Required specific ingredient and nutrition information labeling that defines dietary supplements and classifies them as part of the food supply but allows unregulated advertising
What was the effect of Bioterrorism Act: 2002?
Enhanced controls on dangerous biologic agents and toxins.
Seeks to protect safety of food, water, and drug supply
What was the effect of Food&DrugAdministration Amendments Act: 2007?
Grants FDA greater authority over drug marketing, labeling, and direct-to-consumer advertising;
- requires post-approval studies,
- establishes active surveillance systems,
- makes clinical trial operations
- results more visible to the public
“Right” dose must balance what?
benefits and risks across all patients
Describe how a drug makes it to the market place
- year 0-2, in vitro studies, biologic products, chemical synthesis, optimization along which finds the lead compound
- years 2-4, animal testing determines the efficacy selectivity mechanism
- years 4-8, undergo drug metabolism and safety assessment with use of phase I, II and III testing
- Phase I => 20-100 subjects (is it safe, pharmacokinetics)
- Phase II => 100-200 patients (work in patients?)
- Phase III=> 1000-6000 patients (work, double blind?)
- years 8-9, NDA (new drug application)
- years 9-20, marketing via phase 4 with postmarketing surveillance
- year 20, generics become available
