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Number of FDA Port of Entry Agents Up

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FDA outlines for the House Energy and Commerce Committee its staffing levels of Port of Entry special agents tasked with stopping ...

FDA Speeding Drug Approvals: Pitts

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Former FDAer Peter Pitts praises agency efforts to speed approval of generic and branded drugs.

FDA Science Advisory Board Meeting 12/4-5

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Federal Register notice: FDA announces a 12/4-5 meeting of the Science Advisory Board to the National Center for Toxicological Res...

Implantable Orthopedic Device Reprocessing Petition

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A University of Toledo professor says FDA should stop clearing or approving reprocessing of pedicle screws and other implantable o...

SciGen Recalls Irbesartan for Contamination Potential

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FDA says SciGen is recalling specific lots of its irbesartan due to a potential for contamination.

Vanda Web Page for 2 Drugs False, Misleading: OPDP

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CDERs Office of Prescription Drug Promotion warns Vanda about a Web page promoting its Fanapt and Hetlioz that doesnt contain any ...

Keytruda with Chemo Approved for Lung Cancer

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FDA approves Mercks Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment ...

FDA Pulls 2 Medical Device Proposed Rules

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FDA says it will pull two proposed regulations that need further work if they are to be finalized.

Court Backs FDA in MiraLax OTC Decision

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The DC Circuit Appeals Court says FDA did not act arbitrarily or capriciously in determining that there is no meaningful differenc...

Information Collection Extension for Bar Code Labels

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Federal Register notice: FDA seeks comments on an information collection extension entitled Bar Code Label Requirement for Human D...