October 2, 2018
- Drugs@FDA Data Files (updated)
- FDA D.I.S.C.O.: Olaparib for gBRCAm HER2-negative metastatic breast cancer - Podcast
- FDA D.I.S.C.O.: Olaparib for gBRCAm HER2-negative metastatic breast cancer - Transcript
- FDA Drug Shortages
- Trifluoperazine Hydrochloride Tablets (New - Currently in Shortage)
- Manual of Policies and Procedures (MAPP) 5231.1 CDER Barcode Inquiries (PDF - 84KB)
- Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use Guidance for Industry (PDF - 167KB)
- Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 195KB)
- Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs Guidance for Industry (PDF - 71KB)
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