July 10, 2019
- CDER Bio - Elizabeth Jungman, J.D., M.P.H., Director, Office of Regulatory Policy
- D rug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Manual of Policies and Procedures (MAPP) 4191.1 Risk Evaluation and Mitigation Strategies Modifications and Revisions
- FDA Drug Shortages
- Buspirone HCl Tablets (Updated - Currently in Shortage)
- Carbidopa and Levodopa Extended Release Tablets (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dicyclomine Oral Tablets/Capsules (Updated - Currently in Shortage)
- Diphenhydramine Injection (Updated - Currently in Shortage)
- Eprosartan Mesylate Tablets (Updated - Currently in Shortage)
- Ketamine Injection (Updated - Currently in Shortage)
- Ketoprofen Capsules (Updated - Currently in Shortage)
- Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
- Thiothixene Capsules (Updated - Currently in Shortage)
- Trifluoperazine Hydrochloride Tablets (Updated - Currently in Shortage)
- Using the Inactive Ingredient Database Guidance for Industry
- Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry
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