April 21, 2009Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Source: www.fda.gov FDA Alerts the Public to Uncle Chen and Lian How Brand Expanded Recall The U.S. Food and Drug Administration (FDA) is alerting the public to the expanded, voluntary recall by Union International Food Company (Union City, Calif.) of sauces, oils, and oil blends sold under the Uncle Chen and Lian How brands. Source: www.fda.gov FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml FDA Announces Extension of Enforcement Discretion Related to Morphine Sulfate Oral Solution 20 mg/ml Source: www.fda.gov CDER Organization Charts CDER Organization Charts (updated) Source: www.fda.gov Guidance for Industry Q10 Pharmaceutical Quality System Source: www.fda.gov FDA Serves Warrant for Inspection of Westco Fruit and Nuts Inc. At the request of the U.S. Food and Drug Administration, U.S. Marshals today executed an inspection warrant at Westco Fruit and Nuts Inc. (Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products, such as peanuts. Source: www.fda.gov FDA Imposes Restrictions on Coast IRB due to Violations The U.S Food and Drug Administration today announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials. Source: www.fda.gov Guidance for Industry Newly Added Bioequivalence Recommendations Source: www.fda.gov # posted by Network @ 10:18 AM
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