The Knowledge Shelf

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs.

Generic medications are just as safe and effective as their brand-name counterparts, and often cost less. To help educate patients about FDA’s rigorous review process, the economics of pricing, and related issues, FDA offers a range of educational materials, including videos, graphics, fact sheets,.

Overview of the FDA review and approval process for generic drugs

Generic medicine facts, questions and answers, and FDA review and approval process.

Webinar to discuss the deemed final order (DFO) for over-the-counter (OTC) sunscreen drugs and proposed order for OTC sunscreen drugs

The Sunscreen Innovation Act (SIA) was enacted on November 26, 2014 to provide an alternative process for the review of safety and effectiveness of nonprescription sunscreen active ingredients.

How you use sunscreens, and what other protective measures you take, make a difference in how well you are able to protect yourself and your family from sunburn, skin cancer, early skin aging and other risks of overexposure to the sun.

Review the latest news from the Office of Prescription Drug Promotion.

Drug Information for Health Care Professionals, including drug labeling and safety information.

Sprout Organics has initiated a voluntary recall of one lot of Sprout Organics® Sweet Potato Apple and Spinach because it may contain elevated levels of lead.

Bioresearch Monitoring Information System (BMIS) background page with download file.