What's New on the FDA Drugs Site
September 25, 2015
- Bioresearch Monitoring Information System Download (updated)
- Bioresearch Monitoring Information System Search (updated)
- Clinical investigator Inspection List Download (updated)
- Clinical Investigator Inspection List Search (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus
- FDA Drug Safety Communication: Spanish: La FDA está evaluando los riesgos del uso del medicamento para el dolor tramadol en niños de 17 años de edad y menos
- FDA Drug Shortages
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Calcium Chloride Injection, USP (Updated - Currently in Shortage)
- Cefazolin Injection (Updated - Currently in Shortage)
- Cefepime Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection Bags (Updated - Currently in Shortage)
- Dextrose Injection USP, 70% (Updated - Currently in Shortage)
- Doxorubicin (Adriamycin) Injection (Updated - Currently in Shortage)
- Epinephrine 1mg/mL (Preservative Free) (Updated - Currently in Shortage)
- Epinephrine Injection (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Imipenem and Cilastatin for Injection, USP (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Magnesium Sulfate Injection (Updated - Currently in Shortage)
- Meropenem for Injection, USP (Updated - Currently in Shortage)
- Metoprolol Injection (Updated - Currently in Shortage)
- Pancuronium Bromide Injection (Updated - Currently in Shortage)
- Phosphate (Glycophos) Injection (Updated - Resolved)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Tobramycin Injection (Updated - Currently in Shortage)
- Vancomycin Hydrochloride for Injection, USP (Updated - Currently in Shortage)
- Guidance for Industry: M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes (PDF - 729KB)
- National Drug Code Directory
- Seventh Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2014 (PDF - 2,485KB)
- The Sun and Your Medicine
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