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Bioresearch Monitoring Focuses on Clinical Investigators

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CDERs Office of Scientific Investigations says that 45% of its FY 2011 inspections were of clinical investigators.

FDA Wont Post MOU Info in Federal Register

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Federal Register Final rule: FDA will no longer post information in the Federal Register about its written agreements and memorand...

FDA Amends Regs on Carcinogenic Compounds in Animals

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Federal Register Final rule: FDA amends its regulations on compounds of carcinogenic concern used in food-producing animals.

Info on Dietary Supplement Labeling Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on dietary supplement labeling requirements to the Offic...

Panel to Discuss NDA for Short Bowel Syndrome

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Federal Register Notice; FDAs Gastrointestinal Drugs Advisory Committee will meet 10/16 to discuss an NPS Pharmaceuticals NDA for ...

Panel to Discuss Hologic sPMA for Breast Cancer Screening

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Federal Register Notice: FDAs Radiological Devices Panel will meet 10/24 to discuss a Hologic PMA supplement for the Selenia Dimen...

Panel Meeting Canceled

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Federal Register Notice: FDA cancels the 9/14 meeting of the Cardiovascular and Renal Drugs Advisory Committee.

FDA Withdraws 27 Ranbaxy ANDAs

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Federal Register Notice: FDA withdraws approval of 27 Ranbaxy ANDAs that are no longer marketed.

Heart Calcium Scans Best Disease Predictors: Study

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Wake Forest Baptist Medical Center researchers report heart calcium scans to be far superior to other tools in predicting cardiova...

Quality, Reporting Violations Found at NAImco

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FDAs New Orleans District Office warns NAImco about Quality System and Medical Device Reporting violations.