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Center for Drug Evaluation &
Research (CDER) News

July 17, 2009

• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• June First-Time Generic Drug Approvals
• Recall of Propofol Injectable Emulsion, 10 mg/mL 100 mL vials due to presence of elevated endotoxin levels in some vials

July 16, 2009

• Drugs@FDA Download File (updated)
• FDA issues an Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair)
• FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan

July 15, 2009

• Guidance for Industry: Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act
• Guidance for Industry: ANDAs: Impurities in Drug Substances

July 14, 2009

• Drug Shortages: Current Drug Shortages: Methotrexate injection (updated)
• FDA Approves Plan B One-Step and Lowers Age for Obtaining Two-Dose Plan B Emergency Contraception without a Prescription
• Information for Healthcare Professionals: Immunosuppressant Drugs: Required Labeling Changes
• Providing Effective Information to Consumers about Prescription Drug Risks and Benefits: Public Workshop, September 24-25, 2009, Gaithersburg, MD 20877. Meeting Information

July 13, 2009
Guidance for Industry: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application

• Guidance for Industry: Incorporation of  Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting

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