Drugs
Science and Research web pages updated!
- Learn how CDER advances public health with regulatory science
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Science & Research (Drugs) Assessing data about abuse-deterrent opioid formulations
- A scientific discussion of present and future capabilities
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Data and Methods for Evaluating the Impact of Opioid Formulations with Properties Designed to Deter Abuse in the Postmarket Setting: A Scientific Discussion of Present and Future Capabilities Generic version of HIV-1 treatment approved
- Drug is used to treat, prevent HIV infection in adults at high risk
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First Generic Drug Approvals Warnings issued to companies marketing bodybuilding products
- Health risk associated with product use
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FDA issues warning about body-building products labeled to contain steroid and steroid-like substances
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
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- 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
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Recalls & Alerts
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Division of Drug Information (CDER)
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