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
Guidance for Industry, Warning Letters, Postmarket Surveillance Programs
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
FDA takes action against thousands of illegal Internet pharmacies FDA Drug Safety Communication: Ongoing safety review of Parkinson’s drug Mirapex (pramipexole) and possible risk of heart failure FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers
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
Approvals & Clearances
Contact FDA
Division of Drug Information (CDER)
Office of Communications
10001 New Hampshire Avenue
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Silver Spring, MD 20993