Drugs
From our perspective:
- Interchangeable biological products
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From our perspective: Interchangeable biological products 2016 Novel Drug Report
- Annual report outlines new molecular entities, therapeutic biologics
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Novel Drugs Summary 2016 When winter weather threatens:
- Take precautions to ensure the safety of medicines
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Natural Disaster Response First approved drug to treat spinal muscular atrophy
- Rare, genetic disease affects muscle strength, movement
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FDA approves first drug for spinal muscular atrophy
Navigate the Drugs Section
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
Drug Safety
Program Areas
Advisory Committees - Generic Drugs
Guidances (Drugs) Information on Manufacturing and Quality 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