Overview & Basics
Generic medicine facts, questions and answers, and FDA review and approval process.
What Is the Approval Process for Generic Drugs?
Overview of the FDA review and approval process for generic drugs
Patient Education
Generic medications are just as safe and effective as their brand-name counterparts, and often cost less. To help educate patients…
Global Generic Drug Affairs
FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective,…
Office of Prescription Drug Promotion (OPDP) News
Review the latest news from the Office of Prescription Drug Promotion.
Sunscreen: How to Help Protect Your Skin from the Sun
How you use sunscreens, and what other protective measures you take, make a difference in how well you are able…
Sunscreen Innovation Act | SIA
The Sunscreen Innovation Act (SIA) was enacted on November 26, 2014 to provide an alternative process for the review of…
OTC Monograph Reform: OTC Sunscreen Drugs – 12/15/2021
Webinar to discuss the deemed final order (DFO) for over-the-counter (OTC) sunscreen drugs and proposed order for OTC sunscreen drugs
Compounding and the FDA: Questions and Answers
Creating a medication tailored to the needs of an individual patient. FDA answers the “what” and “why” of compounding. From…
Understanding the Risks of Compounded Drugs
Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are…