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FDA Posts 5 Info Collections Approved by OMB

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Federal Register notice: FDA posts five information collections that have been approved by OMB.

FDA Approves Blueprints Gavreto for Some Thyroid Cancers

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FDA approves a broader indication for Blueprint Medicines Gavreto to treat some thyroid cancers.

West Coast Nuclear Pharmacy Compounding Issues

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FDA warns West Coast Nuclear Pharmacy about drug compounding violations and drugs produced or held in insanitary conditions.

Use of Transport Media in Pandemic Q&A

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FDA publishes questions and answers on developing and using transport media during the Covid-19 pandemic.

Fujirebio Diagnostics 510(k) for Alzheimers Diagnostic

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Fujirebio Diagnostics files a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for use in asse...

Transcript of Device User Fee Meeting

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FDA posts a transcript from a 10/27 CDRH public meeting on reauthorizing the Medical Device User Fee Act program that outlined age...

Beta-Lactam Resistance Research Funding Available

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FDA says it is accepting proposals to assess the impact of extended-infusion beta-lactam antibacterial drugs on the development of...

AlloMek Gets Orphan Status for Neurofibromatosis

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FDA grants AlloMek Therapeutics an orphan-drug designation for its macrocyclic MEK kinase inhibitor, CIP-137401, for treating neur...

Mesoblast Gets Fast Track for Remestemcel-L

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FDA grants Mesoblast Ltd. a Fast Track designation for remestemcel-L for treating acute respiratory distress syndrome due to Covid...

AAM Says CRL Timeline Draft Guidance Raises Questions

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The Association for Accessible Medicines asks FDA to clarify several issues from a draft guidance on instances when a generic drug...