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Final Guide Revised on Convalescent Plasma

[ Price : $8.95]

FDA issues a revised final guidance entitled Investigational COVID-19 Convalescent Plasma.

Workshop on Including Older Adults in Trials

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FDA announces a 3/23 virtual public workshop entitled Roadmap to 2030 for New Drug Evaluation in Older Adults.

Info Collection Revision on New Drug Applications

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Federal Register notice: FDA sends to OMB an information collection revision entitled Application for FDA Approval To Market a New...

Alnylam Pharma Awarded Priority Review Voucher

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Federal Register notice: FDA issues a priority review voucher to Alnylam Pharmaceuticals in response to its rare pediatric disease...

Info Collection on Medical Device Tracking

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Device Tracking 21 CFR Pa...

Pandemic Delays FDA Action on Mallinckrodt BLA

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FDA tells Mallinckrodt that pandemic-related travel restrictions make it necessary to defer action pending a site inspection for i...

BrainQ AI for Stroke Gets Breakthrough Status

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FDA grants BrainQs artificial intelligence-powered technology for ischemic strokes a breakthrough device designation.

Reconciliation Bill Gives FDA $500 Million for Covid Activities

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A provision in a budget reconciliation bill moving its way through the U.S. House of Representatives provides FDA with a $500 mill...

Moderna, FDA Talking to Increase Covid Vaccine Vial Doses

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Moderna says it discussing with FDA a proposal to increase Covid-19 vaccine doses in each vial from 10 to 15 doses.

Nasal Spray Recalled Due to Yeast Contamination

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Ndal Mfg Inc. recalls one lot of Manukaguard Allercleanse after determining the products were contaminated with yeast.