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FDA Corrects Regulation on Hearing Process

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Federal Register Final rule: FDA corrects an inaccurate citation in a regulatory hearing process regulation on biological products...

Former AG Blasts Kentucky OxyContin Suit

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Former attorney general Dick Thornburgh says Kentuckys suit seeking damages for illegal use of OxyContin should be rejected.

FDA Approves Amgens Nplate

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FDA approves Amgens Nplate for stimulating blood platelet production in patients with chronic immune thrombocytopenic purpura.

FDA CBE Final Rule Clarifies Newly Acquired Info

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FDA clarifies what it means by newly acquired information that is used to support labeling changes made to medical products in adv...

Carve-out Ruling Could Change Biologics Approach

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Attorney Arnold Friede says FDAs ruling in denying Watsons Camptosar citizen petition on generic labeling carve-outs may lead to a...

FDA Fast Track for Prostate Cancer Drug

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FDA grants OncoGenex a fast track designation for OGX-011 (custirsen sodium), indicated for combination use with docetaxel in trea...

FDA Looking at Vytorin Cancer Risk

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FDA says it is looking into clinical trial reports of a possible association between Vytorin and an increased cancer risk.

Latest FDA-483s, etc. from FOI Posted

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We post to our Web site nine of the latest FDA-483s and related correspondence we have received from FDA pursuant to our Freedom o...

Guidance on Antimicrobial Drugs for Bronchitis

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Federal Register Notice: FDA releases a draft guidance on developing antimicrobial drugs for treating acute bacterial exacerbation...

Safety Labeling Changes Reg Amendments

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Federal Register Final rule: FDA amends regulations on changes to an approved NDA, BLA, or PMA to deem a supplemental application ...