Drugs
Navigate the Drugs Section
Bioterrorism, drug preparedness and natural disaster response
Drug Approvals and DatabasesCDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting.
Drug Safety and AvailabilityMedication Guides, Drug Shortages, Drug Safety Communications and Other Safety Announcements
Development & Approval Process (Drugs)Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.
Looking for FDA Guidance, Compliance, & Regulatory Information? Web page provides quick links to a variety of topics.
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
- New Biosimilar approved to treat cancer
- First monthly therapy for opioid use disorder approved
Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access - FDA Widens Scope of Navigator – Information Tool for Expanded Access
Drug Safety
Program Areas
- Advisory Committees (Drugs)
- Generic Drugs
Guidances (Drugs) Pharmaceutical Quality Resources Regulation of Nonprescription Products Pediatric Product Development CDER Small Business & Industry Assistance (SBIA) - User Fees (BsUFA, GDUFA, PDUFA)
Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
Spotlight
Recalls & Alerts
Approvals & Clearances
Stay Informed
Contact FDA
Division of Drug Information (CDER)
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993