- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection - Drug Information Update
- Generic Drug Review Dashboard as of October 1, 2017 (PDF - 334KB)
- Positron Emission Tomography (PET): Questions and Answers about CGMP Regulations for PET Drugs(updated)
- Drugs@FDA Data Files (updated)
- Evaluating Drug Effects on the Ability to Operate a Motor Vehicle Guidance for Industry (PDF - 104KB)
- FDA Drug Shortages
- Atenolol Tablets (Updated - Currently in Shortage)
- Carbidopa and Levodopa Extended Release Tablets (Updated - Currently in Shortage)
- Dexrazoxane Injection (Updated - Currently in Shortage)
- Guanfacine Hydrochloride Tablets (Updated - Currently in Shortage)
- Mecasermin [rDNA origin] (Increlex) Injection (Updated - Resolved)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Sacrosidase (Sucraid) Oral Solution (Updated - Currently in Shortage)
- REMS Integration Initiative (updated)
- Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry (PDF - 102KB)
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