September 28, 2018
- Evidence-Based Treatment Decisions In Transplantation: The Right Dose & Regimen for the Right Patient/Individualized Treatment (updated)
- Patent Certifications and Suitability Petitions (updated)
- Drug Supply Chain Security Act (DSCSA) (updated)
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Calcium Chloride Injection, USP (Updated - Currently in Shortage)
- Deferoxamine Mesylate for Injection, USP (Updated - Currently in Shortage)
- Dextrose 5% Injection Bags (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Diltiazem Hydrochloride (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution (New - Currently in Shortage)
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Lorazepam Injection, USP (Updated - Currently in Shortage)
- Magnesium Sulfate Injection (Updated - Currently in Shortage)
- Metoclopramide Injection, USP (Updated - Currently in Shortage)
- Metronidazole Injection, USP (Updated - Currently in Shortage)
- Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
- Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Potassium Phosphate Injection (Updated - Currently in Shortage)
- Procainamide Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sterile Water (Updated - Currently in Shortage)
- Manual of Policies and Procedures (MAPP) 4642.3 Student Volunteer Employment Program (SVEP) (PDF - 76KB)
- Guidance for Industry:
- Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications Guidance for Industry and FDA Staff (PDF - 457KB)
- Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry (PDF - 479KB)
- Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 623KB)
- Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 434KB)
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