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Artificial Intelligence Platform Aiding Drug Reviews: Report

[ Price : $8.95]

A GCN report says FDA is relying on the Abbyy digital intelligence platform to analyze and summarize drug safety reports.

Abbott Covid Test EUA Includes Asymptomatic Use

[ Price : $8.95]

FDA grants Abbott an Emergency Use Authorization for over-the-counter, non-prescription, asymptomatic use of its BinaxNow Covid-19...

Apotex Recalls 3 Lots of Guanfacine Extended-Release Tablets

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FDA says Apotex is recalling three lots of Guanfacine extended-release tablets after finding contamination in one lot.

Sanofis Sarclisa Expanded OK in Multiple Myeloma

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FDA approves Sanofis Sarclisa (isatuximab) for combination use with carfilzomib and dexamethasone in treating adult patients with ...

Drug Registration 2016 Rule Corrected

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Federal Register notice: FDA corrects an 8/31/2016 amended final rule that listed inaccurate cross-references to FDAs drug establi...

Review Period Set for Biomimics Vascular Stent

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Veryan Medicals Biomimics 3...

Special Counsel Troubled by FDA Response to Whistleblower

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Special Counsel Henry Kerner says he is troubled by the way FDA handled a whistleblower complaint involving inspections at biologi...

Accelerate Sustainable Capability Pilot Volunteers Sought

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FDA provides information for applying to participate in the Medical Device Innovation Consortium Accelerate Sustainable Capability...

Editorial Changes Made Due to Obsolete FDA Office

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Federal Register notice: FDA amends its medical device regulations to make an editorial nonsubstantive change and replace a refere...

Panel to Discuss BLA for Type 1 Diabetes

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Federal Register notice: FDA announces a 5/27 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Proventio...