- by FDAThe mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. The annual Report on the State of Pharmaceutical Quality is intended to help characterize the quality of the U.S. drug supply chain. Learn more.
- by FDAGeneric Drug Facilities, Sites and Organization Lists
- by FDAQuantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
- by FDAMaster Protocols for Drug and Biological Product Development
- by FDADraft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
- by FDAOn September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022.
- by FDADrugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
- by FDADrug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.
- by FDAThese letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.
- by FDAJuly 18, 2025: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement
- by FDAWant to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
- by FDAFDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer
- by FDAFDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
- by FDAThis page lists Recently Issued CBER and Cross-Center Guidance Documents.
- by FDAGuidance Documents for Rare Disease Drug Development
- by FDALearn about the warnings for sleep, skin and bodybuilding products that contain hidden drugs and other hidden ingredients.
- by FDAThe Food and Drug Administration is advising consumers not to purchase or use PRE-FORMANCE BLACK, a product promoted to boost energy and increase performance on various websites, including Advancedsupps.com, and possibly in some retail stores.
- by FDANews about human drug-related approvals
- by FDAThe U.S. Food and Drug Administration (FDA) has approved Tryngolza (olezarsen), used with diet, to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.
- by FDAOn June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer follo