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FDA Notifies Union on Plans to Outsource 300-plus Jobs

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FDA notifies the National Treasury Employees Union that it had identified 332 positions as commercial in nature, in eight differen...

FDA OKs Caracos Generic Phentermine

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FDA approves a Caraco Pharmaceutical Laboratories ANDA a generic copy of Tevas obesity drug Adipex-P.

Technical Issues Hit FDA Webview

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FDA Webview experiences serious technical issues which impact our service, but we expect to resume normal operations shortly.

Comments Sought on Risk Info in DTC Ads

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Federal Register Notice: FDA seeks comments on communicating risk information in DTC broadcasts ads.

CDRH Ombudsman Resolved 81% of 2006 Cases

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CDRH ombudsman Les Weinstein says he resolved 81% of the cases that came to him last year.

Antibacterial Diarrhea Reported in Labeling

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FDA approves labeling changes for 38 drugs, including that Clostridium difficile-associated diarrhea has been reported with use of...

Merck Adds Birth Defects Precaution to Singulair Label

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Merck adds a new precautions statement about birth defects to its asthma drug Singulair.

Researchers Say Animal Studies Not Useful

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Researchers question the value of some animal studies to human health.

FDA Approves 1st Generic Wellbutrin XL

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FDA rejects a citizen petition and approves the first generic Wellbutrin XL, submitted by Anchen Pharmaceuticals.

FDA Panel Votes Down Hemopure Navy Trial

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FDAs Blood Products Advisory Committee votes against allowing Biopure Corp. to proceed with a U.S. Navy-proposed study with the bl...