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Rx Drug Marketing Information Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Prescription Drug Marketing; Administrative...

House Subcommittee OKs $257 Million FDA Boost

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A House Appropriations Subcommittee approves by voice vote FDAs s fiscal year 2022 budget bill that would increase the agencys bud...

Avid Medical Recalls Convenience Kits

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Avid Medical recalls (Class 1) medical convenience kits that include the BD/Carefusion Chloraprep 3mL applicator due to the risk o...

Register Terminal Cancer Patients in Cancer Trials, FDA Says

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FDA publishes a draft guidance to encourage the inclusion of some patients with incurable cancers in trials of new cancer therapie...

Guide on Trial Master Protocols During Covid-19

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Federal Register notice: FDA makes available a final guidance entitled Covid 19: Master Protocols Evaluating Drugs and Biological ...

Regulatory Review Determined for Zolgensma

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novartis Zolgensma.

Bill Would Create New Health Advanced Research Agency

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Reps. DeGette and Upton propose language for a Cures 2.0 bill circulating in Congress to create the Advanced Research Projects Age...

ODAC Recommends Deferring Action on Retifanlimab

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The Oncology Drug Advisory Committee recommends that FDA not take action to approve Incytes retifanlimab for squamous carcinoma of...

Genentech BLA for Wet AMD Implant Submitted

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FDA accepts for priority review a Genentech BLA for its Port Delivery System with ranibizumab for treating wet age-related macular...

Workshop on Leukoencephalopathy Trials

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Federal Register notice: FDA announces a 9/21 public workshop entitled Considerations for Progressive Multifocal Leukoencephalopat...