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BMS Opdivo High Risk Urothelial Carcinoma OKd

[ Price : $8.95]

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

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FDA posts a revised draft guidance entitled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an AND...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

FDA Says Pfizer Expands Chantix Recall Again

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FDA says Pfizer has recalled four additional lots of Chantix due to the presence of an unacceptable level of N-nitroso-varenicline...

FDA Fast Track Designation for Senhwas Silmitasertib

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FDA grants fast track designation to Senhwa Biosciences silmitasertib for treating recurrent sonic hedgehog medulloblastoma.

FDA Clears Qure.ai qER-Quant for Brain CT Scans

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FDA clears a Qure.ai brain imaging quantification product.

Drug, Device Recalls Continue to Go Down: Sedgwick

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The Sedgwick recall index says both medical device and pharmaceutical recalls continued to drop in the second quarter of 2021, hit...

FDA Clears Zimmer Biomet Rosa Hip

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FDA clears a Zimmer Biomet 510(k) for its Rosa Hip System for robotically-assisted direct anterior total hip replacement.