Drug Approvals and Databases
- Acronyms and Abbreviations Search
More information - Approved Risk Evaluation and Mitigation Strategies (REMS)
- Bioresearch Monitoring Information System (BMIS) Search
More information - Clinical Investigator Inspection List (CLIIL) Search
More information - Dissolution Methods Database Search
More information - Drug Establishments Current Registration Site Search
More information - Drug Safety-related Labeling Changes (SrLC)
More information - Drug Shortages
More information - Drugs@FDA Search
More information - FDA Adverse Event Reporting System (FAERS) Quarterly Data Files
Downloadable data files. - FDA Adverse Event Reporting System (FAERS) Public Dashboard
- Inactive Ingredient Search for Approved Drug Products Search
More information - Medication Guides Search
More information - National Drug Code Directory Search
More information - Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) Search
More information - OTC Monographs@FDA
- Outsourcing Facility Product Report
- Postmarket Requirements and Commitments Search
More information - President's Emergency Plan for AIDS Relief (PEPFAR) Database
More Information - Product-Specific Guidances for Generic Drug Development Database
More Information - Purple Book (database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products)
More Information - Wholesale Distributor and Third-Party Logistics Providers Reporting
More information
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Resources For You
- Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals
- Drug and Biologic Approval and IND Activity Reports
- Drug Trials Snapshots
- Oncology (Cancer) / Hematologic Malignancies Approval Notifications
- FDALabel
- FDA Online Label Repository
- FDA’s Labeling Resources for Human Prescription Drugs
- New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
- This Week's Drug Approvals