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Priority Review for Enhertu sBLA in HER2 Low Breast Cancer

[ Price : $8.95]

FDA accepts for priority review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu (fam-trastuzumab deruxtecan-nxki) fo...

Expanding Use of Remote Regulatory Assessments: Guide

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FDA releases a draft guidance on the expanded use of remote regulatory assessments beyond the Covid-19 pandemic to assess an FDA-r...

3 NDAs Withdrawn Over Annual Reports

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Federal Register notice: FDA withdraws approval of three NDAs from multiple holders because they repeatedly failed to file require...

Regulatory Review Period for Lillys Tauvid

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Eli Lillys Tauvid (flortauc...

Real-time Oncology Review Draft Guide

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Federal Register notice: FDA makes available a draft guidance entitled Real-Time Oncology Review (RTOR) that provides recommendati...

Cavazzoni Sees ctDNA Endpoint as Promising

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CDER director Patrizia Cavazzoni tells Friends of Cancer Research that the potential use of circulating tumor DNA as an endpoint t...

Failure to Respond to ANDA Complete Response Letters: Guide

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FDA releases a final guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.

FDA Posts Q & A Guide on Orange Book

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FDA posts a final guidance entitled Orange Book Questions and Answers that answers commonly asked questions it has received from i...

Compliance Extension Date on Unique Device IDs

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FDA posts an updated final guidance entitled on the unique device identification compliance date for class i and unclassified devi...

FDA Proposes to Move to 12-digit National Drug Codes

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Faced with running out of 10-digit codes, FDA proposes to move to a 12-digit format for national drug codes.