-
1. First United States Pharmacopeia (USP) in USP
---
-
2. Import Drug Act of 1848
(Story: Due to US Mexican War)
It mandated inspection prior to admission to the country
-
3. The Bureau of Chemistry founded (1862)
---
-
4. Upton Sinclair wrote about unsanitary conditions (1901)
---
-
5. Biologics Control Act (1902)
(Story: deaths of children caused by contaminated vaccines)
Safety, purify, and effectiveness of biological products
(Led to formation of CBER, a predecessor of the FDA)
-
6. Pure Food and Drugs Act (1906)
Prohibit interstate commerce of misbranded and adulterated food, drinks, drugs. Precursor to FDA formation.
-
7. Sherley Amendment (1912)
Prohibit false therapeutic claims
-
-
9. Federal Food, Drug, and Cosmetic Act (1938)
(Story: deaths due to diethylene glycol was used to dissolve sulfanilamide meds to make a liquid form)
Required animal tests. Law has been amended many times.
-
10. Durham-Humphrey Amendment to the Act of 1938 (1951)
"Prescription Amendment". Differentiate between OTC and prescription drugs. PHoen prescription and refill.
-
11. Kefauver-Harris Amendment (1962)
- (Story: Thalidomide disaster)
- Need to prove effectiveness to FDA before marketing a drug.
-
12. Drug Listing Act (1972)
Give FDA a list of all their drugs by NDC, a unique product identifier.
-
13. Orphan Drug Act (1983)
Designed to facilitate the development and commercialization of drugs to treat rare disease.
-
14. Drug Price Competition and Patent Restoration Act (1984)
Provides for a period fo exclusivity such that once a New Molecular Entity (NME) is approved, a generic version cannot be approved for 5 years.
-
15. Revision of New Drug Application (NDA) regulations (1985)
These changes provide for safety reports after an application for a new drug is submitted, more focused and better organized data, use fo summaries and tables for easier review, etc
-
16. Drug Exports Amendments (1986)
Can export meds to other countries even if it's not approved by the FDA.
-
17. Prescription Drug Marketing Act (1987)
Prevent illegal diversion and sale of prescription drugs from legitmate distributors.
-
18. Revision of Investigational New Drug (IND) Regulations (1987)
-
19. Treatment use of INDs (Investigational New Drug) (1987)
Made promising new drugs available to desperately ill patients as early in the drug development process as possible.
-
20. Generic Drug Enforcement Act (1992)
-
21. Prescription Drug User Free Act (PDUFA) (1992)
|
|
