What's New on the FDA Drugs Site
September 1, 2017
- FDA alerts health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes manufactured by Foshan Flying Medical Products
- FDA-NCI Public Workshop: Defining Disease Recurrence and Harmonizing Conduct in Adjuvant Bladder and Kidney Cancer Trials
- Draft Guidance: Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Approval Package
- FDA approves Mylotarg (gemtuzumab ozogamicin) for treatment of acute myeloid leukemia
- Hospira Issues Voluntary Worldwide Recall For Lots of Hydromorphone HCl Injection, USP, CII, (2 mg/mL) 1mg/mL Vial, and Levophed (Norepinephrine Bitartrate Injection, USP), 4 mg/4 mL (1 mg/mL) Vial, Due to a Lack of Sterility Assurance
- Manual of Policies and Procedures (MAPP): Filing Review of Abbreviated New Drug Applications (PDF 521KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- FDA Approves Gemtuzumab Ozogamicin for CD33-positive AML
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