Drugs
Join regulatory educators from FDA’s CDER and CDRH
- Learn helpful information on key aspects of drug, device regulations
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FDA Small Business Regulatory Education for Industry (REdI): Fall Conference September 27-28, 2017 President signs the FDA Reauthorization Act of 2017
- Law revises, reauthorizes Agency’s user-fee programs for medical products
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FDA User Fee Programs New treatment for adults with cancer of the blood, bone marrow
- Drug binds to B-cell acute lymphoblastic leukemia cancer cells
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FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia New drug approved for chronic hepatitis C virus genotypes 1-6
- Therapy provides shorter treatment durations for many patients
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FDA approves Mavyret for Hepatitis C
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 (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
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Division of Drug Information (CDER)
Office of Communications
10001 New Hampshire Avenue
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Silver Spring, MD 20993