Medicamentos
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New therapy for treatment-resistant myeloma
- Helps immune system destroy cancerous cells
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FDA approves Pomalyst for advanced multiple myeloma CDER highlights in 2012
- Senior manager presentations
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Several presentations recap CDER in 2012 Safe Drug Use After a Natural Disaster - Tips for drug safety after disasters
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Safe Drug Use After a Natural Disaster New drug helps urea cycle process
- Attacks life-threatening genetic disorder
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FDA approves new drug for the chronic management of some urea cycle disorders
Drugs Topics
Preparación para emergencias
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
Pautas, cumplimiento e información regulatoria
Guidance for Industry, Warning Letters, Postmarket Surveillance Programs, Rules and Regulations
Noticias y eventosWhat'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
Recursos para ustedFor Consumers, Health Professionals, Industry
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Program Areas
Comités asesores - Medicamentos genéricos
Guidances (Drugs) General Information on Manufacturing and Product Quality Regulation of Nonprescription Products Pediatric Product Development Ayuda a pequeños negocios - User Fees (BsUFA, GDUFA, PDUFA)
Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
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