What's New on the FDA Drugs Site
January 13, 2017
- Drug Trials Snapshots: SPINRAZA
- FDA Drug Shortages
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Cefepime Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Methylprednisolone Sodium Succinate for Injection, USP (Updated - Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Ranitidine Injection, USP (Updated - Currently in Shortage)
- Scopolamine (Transderm Scop) Transdermal System Patch (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Update: FDA revises final guidances on interim policy for certain bulk drug substances used in compounding
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry (PDF - 134KB) - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Guidance for Industry (PDF - 112KB) - Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (PDF - 200KB)
- Referencing Approved Drug Products in ANDA Submissions Guidance for Industry (PDF - 155KB)
.png)
No hay comentarios:
Publicar un comentario