Drugs
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FDA wants input about HIV's impact
- Public meeting scheduled June 14
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Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research When weather attacks
- Keeping safe, healthy after storms
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Natural Disaster Response Have fun in the sun...
- Just keep the lotion close!
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Sunscreen New use for arthritis drug Simponi
- Now treats inflammation in intestines
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FDA approves Simponi to treat ulcerative colitis
Navigate the Drugs Section
Emergency Preparedness
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, Compliance & Regulatory Information
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
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News and Announcements
FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee FDA approves Simponi to treat ulcerative colitis FDA approves new drug for advanced prostate cancer FDA approves Nymalize--first nimodipine oral solution for use in certain brain hemorrhage patients
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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
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