Doctors and the FDA
What Are Drugs?
What Are Devices?
What Are Biologics, Biological Products and Biological Drugs?
What Are Combination Products?
What Are Dietary Supplements and Nutraceuticals?
What Are Cosmetics and Cosmeceuticals?
What Is the FDA and What Does It Do?
Foods, Doctors and the FDA
The FDA Approval Process and Drug Development
The New Drug Application (NDA), the Investigative New Drug Exemption (IND) and the General Drug Approval Pathway
FDA and Tobacco Products
FDA Advisory Committees
FDA, Labels and Labeling for Medical Products
FDA and Product Names
FDA and Promotion and Advertising
Off-Label Use
Additional Drug Approval Pathways and Expanded Access (Treatment INDs); and Personal Importation of Unapproved Drugs
FDA Exclusivity and Patents
Adverse Event Reporting, Pharmacovigilance and FDA
FDA Rule Making and Guidances
Enforcement and Warning Letters
The FDA, Politics and Criticism
Brief History of the FDA.