Drugs
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Two deaths from antipsychotic drug
- Unexplained events being investigated
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FDA Drug Safety Communication: FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate) Stop, look, look again
- Protect against tampering
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Protect Yourself Against Tampering Expanded use of Xgeva approved
- Treats non-cancerous bone tumors
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FDA approves Xgeva to treat giant cell tumor of the bone Forum brings educators together
- Obtain drugs, devices information
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FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2013
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 Voice Blog: The road ahead for ensuring access to quality drugs for all Americans… new laws under “FDASIA” will help pave the way FDA Drug Safety Communication: FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate) Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination FDA Voice Blog: Avandia: Hearing all Sides in Scientific Debate
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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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