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Legitimate Drug Imports Delayed Due to Coding Issues: FDA

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FDA says legitimate product imports into the U.S. are being unduly delayed because of missing affirmations of compliance or improp...

CBER Expands Direct Recall Classification to Biologic Products

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CBER begins a direct recall classification process to expedite recall matters involving biological products.

FDA Corrects Notice on Data Exchange Meeting

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Federal Register Request for comments, correction: FDA corrects an e-mail address in an 8/14 notice announcing a meeting entitled,...

Comments Extended on Unique Device ID

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Federal Register Notice: FDA extends the comment period on a proposed rule on the unique identification system.

Info on Selenium Cancer Risk Sent to OMB

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Federal Register Notice: FDA sends a collection of information to OMB on consumer responses to claims about the relationship betwe...

Pediatric Panel to Discuss 4 Oncology Products

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 12/4 to discuss pediatric development plans for four produ...

FDA OKs Lannett Co. Generic ANDA for Tension Headaches

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FDA approves a Lannett Co. ANDA for butalbital, acetaminophen and caffeine tablets a generic of Fioricet, indicated to treat tensi...

House Passes Continuing Resolution for FDA, Other Agencies

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The U.S. House passes a continuing resolution (H.J.Res. 117) that would fund FDA and the rest of government until 3/27/2013 at cur...

Sequestration Report Targets $319 Million in FDA Cuts Next Year

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A White House Office of Management and Budget preliminary report indicates that FDAs budget would be slashed $319 million (8.2%) u...

FDA Policy Guru David Dorsey Joining Janssen

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FDA acting associate commissioner for policy and planning David Dorsey announces his departure to join Janssen Research & Developm...