Drug Approval Process

Question 1

Pure Food and Drug Act of 1906 Provision

Answer 1

Required accurate labeling of the ingredients in drug products and sought to prevent the adulteration of products; no requirement of proven safety or efficacy to market drugs

Question 2

Food, Drug and Cosmetic Act of 1938 Provision

Answer 2

Required any new drug to be evaluated for safety for the labeled use by its manufacturer before marketing; established FDA

Question 3

Durham-Humphrey Amendment of 1952 Provision

Answer 3

Created a legal distinction between nonprescription and prescription drugs

Question 4

Kefauver-Harris Amendments of 1962 Provision

Answer 4

Pharmaceutical companies required to prove efficacy and safety for the labeled indication before FDA approval for marketing

Question 5

Orphan Drug Amendments 1983 Provision

Answer 5

Provided tax benefits and other incentives for manufacturers to test and produce drugs to treat rare diseases

Question 6

Drug Price Competition & Patent Restoration Act of 1984 Provision

Answer 6

Extended the patent life of drug products by the amount of time required for regulatory review of a NDA; accelerated the approval of generic drugs by allowing submission of an abbreviated NDA

Question 7

Accelerated Drug Approval 1992 Provision

Answer 7

Authorized accelerated drug approval for new drugs to treat life-threatening conditions such as AIDS and cancer

Question 8

Drug Development in the United States (7 Steps)

Answer 8

1. Discovery and Characterization of New Drug
2. Pre-Clinical Studies
3. IND Application
4. Clinical Studies
5. Submission of NDA
6. Approval of NDA
7. Postmarketing Surveillance

Question 9

Discovery and Characterization of New Drug

Answer 9

• Isolate or synthesize a new drug

* Determine chemical/pharmaceutical properties of new drug

Question 10

Pre-Clinical Studies

Answer 10

• Determine pharmacokinetic and pharmacodynamic properties of drug
• Animal testing for toxicity, teratogenesis, mutagenesis, and carcinogenesis

Question 11

IND Application

Answer 11

• Outline properties of the drug
• Report results of studies to date
• Propose clinical studies (protocols, data analysis methods, etc.)

Question 12

Clinical Studies

Answer 12

• Phase I: drug safety and pharmacokinetics in healthy volunteers
• Phase II: efficacy, safety, and proper dose in small group of patients
• Phase III: statistical evidence of drug safety and efficacy

Question 13

Submission of NDA

Answer 13

• Outline properties of the drug
• Report results of all experimental and clinical studies
• Propose labeling of drug and clinical indications for use

Question 14

Approval of NDA

Answer 14

• Marketing of drug

Question 15

Postmarketing Surveillance

Answer 15

• Gather and analyze voluntary reports of adverse effects