Drugs
Drugs Topics
Bioterrorism, drug preparedness and natural disaster response
Drug Approvals and DatabasesDrug-Related Databases from FDA; Information on Drug Approvals
Drug Safety and AvailabilityMedication Guides, Drug Shortages, Drug Safety Communications and Other Safety Announcements
Development & Approval Process (Drugs)Conducting Clinical Trials, Types of Drug Applications, Forms and Submissions Requirements, Labeling Initiatives, Drug and Biologic Approval Reports
Guidance for Industry, Warning Letters, Postmarket Surveillance Programs, Rules and Regulations
News & EventsWhat's New on This Site, Drug Approval Listing, Meetings and Conferences
Science & Research (Drugs)Research by FDA Staff to Evaluate and Enhance the Safety of Drug Products
Resources for YouFor Consumers, Health Professionals, Industry
News and Announcements
- October 29 and 30, 2012 - CDER Drug Safety and Risk Management Advisory Committee meeting has been postponed
- FDA approves Synribo for chronic myelogenous leukemia
FDA Drug Safety Communication: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays FDA approves Fycompa to treat seizures
Program Areas
Advisory Committees - Generic Drugs
Guidances (Drugs) General Information on Manufacturing and Product Quality Regulation of Nonprescription Products Pediatric Product Development Small Business Assistance - User Fees (BsUFA, GDUFA, PDUFA)
Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
Contact FDA
Division of Drug Information (CDER)
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993