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Comments Sought on IND Reporting Requirements Extension

[ Price : $8.95]

Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend an information collection related to Inves...

FDA Urges Public to Report Device Regulatory Misconduct

[ Price : $8.95]

FDA urges the public and industry insiders to report regulatory misconduct against medical device manufacturers or individuals mar...

FDA/CMS Formally Implement Parallel Review Program

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Federal Register Notice: FDA and CMS announce their intention to fully implement their joint parallel review pilot program.

Comments Sought on Dear Doctor Letters

[ Price : $8.95]

Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend an information collection related to a gui...

FDA, CMS Make Parallel Review Program Permanent

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FDA and CMS announce that their ongoing medical device parallel review pilot program will be fully implemented and extended indefi...

Hill Interest Grows Over Late Device Adverse Events

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In response to another Star Tribune article questioning late medical device reporting to FDA, Sen. Al Franken (D-MN) says he conti...

FDA Approves Updated Label for Xtandi in Prostate Cancer

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FDA approves an Astellas Pharma and Pfizer supplemental NDA to change product labeling for Xtandi (enzalutamide) capsules to inclu...

Newron Refiles NDA for Parkinsons Drug

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Newron Pharmaceuticals resubmits an NDA for safinamide, indicated for treating patients with Parkinsons disease.

FDA Approves Roche cobas MPX Test for Blood Donors

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FDA approves a Roche PMA for the cobas MPX test for use on the cobas 6800 and 8800 Systems for use at blood donor screening labora...

Comments Sought on Animal Drug User Fee Cover Sheet

[ Price : $8.95]

Federal Register Notice: FDA asks for comments on a submission to OMB seeking to extend an information collection related to requi...