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Drug User Fee Reauthorization Meeting

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Federal Register notice: FDA announces a 9/28 virtual public meeting entitled Reauthorization of the Prescription Drug User Fee Ac...

Argyle UVC Insertion Tray Class 1 Recall

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Cardinal Health recalls its Argyle UVC Insertion Tray because it does not include specific instructions for using the safety scalp...

Info Collection on Drug Compounding

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Federal Register notice: FDA sends to OMB an information collection revision on human drug compounding, repackaging, and related a...

Guide on Bioequivalence Studies with Pharmacokinetic Endpoints

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FDA posts a revised draft guidance entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an AND...

Biden Retreats From Woodcock Commissioner Nomination

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The Biden Administration reportedly rules out nominating FDA acting commissioner Janet Woodcock for the agencys top post due to la...

CDER Examining Misleading Images in DTC Ads

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CDER drug promotion researchers evaluate how images can offer misleading perceptions in direct-to-consumer drug ads, and develop v...

Ortho-Cept Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA has determined that Janssen Pharmaceuticals Ortho-Cept (desogestrel-ethinyl estradiol) 21- and 28-day...

FDA Cautions on Robot Surgical Devices for Mastectomies

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FDA issues a safety alert reminding patients and health care providers that the safety and effectiveness of robotically-assisted s...

BMS Opdivo High Risk Urothelial Carcinoma OKd

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FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinoma who are at ...

FDA Grants Covis Hearing Request on Makena

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FDA approves a Covis Pharma request for a hearing on CDERs proposal to withdraw approval for Makena.