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FDA Approves Merck C-diff Recurrence Reducer

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FDA approves a Merck NDA for Zinplava (bezlotoxumab) injection 25 mg/mL, indicated for reducing recurrence of Clostridium difficil...

FDA Clears Ortho Clinical Automated Blood Analyzer

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FDA clears an Ortho Clinical Diagnostics 510(k) for the Ortho Vision Max, an automated blood analyzer for high-volume transfusion ...

Hospital Inspections Identify Need for Improved Event Reporting

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CDRH seeks to improve medical device post-market data by improving hospital (user) reporting of adverse events.

FDA DTC Study on Animation Activities Moving Forward

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FDA advances a planned direct-to-consumer (DTC) advertising study that is intended to research the growing use of animation in pre...

Comments Sought on IND Reporting Requirements Extension

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

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...