Drug Approvals and Databases | FDA
Sep 24, 2025 · CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting.
U.S. Food and Drug Administration
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the ...
Drugs | FDA
Drugs@FDA Find information about most FDA-approved prescription, generic, and over-the-counter drug products. Drug Shortages Find information about drug shortages caused by manufacturing and ...
Approved Drugs: Questions and Answers | FDA
Approved Drugs: Questions and Answers How is a medicine approved by FDA? Drug companies seeking approval to sell a drug in the United States must test it.
Approvals of FDA-Regulated Products
Drugs@FDA Postmarket Drug Safety Information for Patients and Providers Prescription Drug User Fee Amendments Biological Products Vaccines, tissue, blood, and other products derived from living ...
Development & Approval Process | Drugs | FDA
Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.
Is It Really 'FDA Approved'?
The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and ...
Novel Drug Approvals for 2025 | FDA
Feb 27, 2026 · FDA Novel Drug Therapy Approvals for 2025 In 2025, CDER approved 46 new drugs never before approved or marketed in the U.S., known as “novel” drugs.
Novel Drug Approvals at FDA
What are "Novel" Drugs? "Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products ...
About FDA Product Approval
Approvals of FDA-Regulated Products The Food and Drug Administration's regulatory approaches to marketing approval of the products it regulates are as varied as the products themselves. These ...