Drug Approvals and Databases | FDA - U.S. Food and Drug Administration
Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. Additional topics include: approved REMS, drug shortages, and the...
Approvals of FDA-Regulated Products | FDA - U.S. Food and Drug ...
Instruments or products used for treating or diagnosing disease (such as thermometers, artificial hearts, and home pregnancy test kits)
Is It Really 'FDA Approved'? - U.S. Food and Drug Administration
2022年5月10日 · New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product...
Drugs@FDA - Food and Drug Administration
Drugs@FDA allows you to search for official information about FDA approved innovator (brand name) and generic drugs and therapeutic biological products. Drugs@FDA contains information...
FDA approved vs. FDA cleared: Why you need to know the …
2019年6月2日 · What does 'FDA approved' mean? "FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use." Manufacturers must...
New FDA Drug Approvals for 2025 - Drugs.com
Up to date information on the latest FDA drug approvals. Includes list of most recent approvals, the conditions approved for, and the approval history.
FDA Expands Approval of Pluvicto in PSMA-Positive mCRPC
1 天前 · The FDA has expanded the approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to include patients with PSMA-positive mCRPC who have been treated with ARPI therapy and can delay chemotherapy.
Drugs | FDA - U.S. Food and Drug Administration
Find information about most FDA-approved prescription, generic, and over-the-counter drug products. Find information about drug shortages caused by manufacturing and quality problems, delays,...
FDA Label Search
Drugs @ FDA, where information about FDA-approved human brand name and generic drugs as well as therapeutic biological products is available. Biologics Products and Establishments , where...
FDA Cleared vs. FDA Approved: What’s the Difference?
2025年3月17日 · What Does FDA Approved Mean? FDA approval is a more stringent process required for drugs and high-risk medical devices. This process involves substantial clinical trials to prove safety and efficacy. Products that require FDA approval go through the Premarket Approval (“PMA”) process, which involves extensive research, human trials, and ...