June 28, 2018
- CDER Statement: FDA Approves Labeling Supplement for Celebrex (celecoxib)
- Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (PDF - 447KB)
- FDA Drug Shortages
- Telmisartan Tablets (New - Discontinuation)
- Zolpidem Tartrate (Edluar) Sublingual Tablets (Updated - Currently in Shortage)
- Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry (PDF - 263KB)
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