February 25, 2019
- Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations (PDF - 153KB)
- Bioavailability Studies Submitted in NDAs or INDs – General Considerations (PDF - 254KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity
- National Drug Code Directory (updated)
- Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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