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Implantable Orthopedic Device Reprocessing Petition

[ Price : $8.95]

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 ...

QS Violations Seen in Leventon Inspection

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FDA warns Spains Leventon S.A.U. about Quality System violations in its manufacturing of Dosi Flow infusion pumps and administrati...

Warnings Sought on Isotretinoin Sexual Effects

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Three medical school professors ask FDA to add warning language about sexual side effects to labeling for all drug products contai...

Draft Guide on Dried Plasma Products

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Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Development of Dried Plasma Products...

10 NDA Approvals Withdrawn by FDA

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Federal Register notice: FDA withdraws approval of 10 NDAs from multiple applicants after they notified the agency that the drug p...

FDA Details Device Accreditation Scheme for Conformity Assessment

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FDA posts details of an Accreditation Scheme for Conformity Assessment (ASCA) pilot program that aims to enhance the predictabilit...

Additional GDUFA Resources Having Positive Impact: Analysis

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An FDA analysis says more ANDAs could be approved in the first cycle if sponsors ensured their applications were complete at the t...