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Biotricity Gains Clearance for Bioflux Software

[ Price : $8.95]

FDA clears a Biotricity 510(k) for its Bioflux Software II System.

FDA Nimble in Pandemic Responses: Azar

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HHS secretary Alex Azar says FDA moved quickly to remove KN95 masks from Chinese manufacturers that didnt have required independen...

Comments Sought on International Controls on 11 drugs

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Federal Register notice: FDA seeks comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of sched...

FDA Encouraging Advanced Manufacturing

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FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah describe agency steps to promo...

GSK, Sanofi Report Zantac-related Probes

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GlaxoSmithKline (XXX DELETE XXX)and Sanofi separately disclose that they are being investigated by the U.S. Justice Department ove...

Ex-FDA Commissioners Urge Coordinated Covid-19 Plasma Effort

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Four former FDA commissioners urge U.S. regulators, researchers and Covid-19-recovered patients to join in an effort to collect bl...

Biosimilar User Fee Rates for FY 2021

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Federal Register notice: FDA announces the rates for biosimilar user fees for fiscal year 2021.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Acrx Specialty Pharmacy, Fishman Chemical and MMSTabs.com.

Drug User Fee Rates for FY 2021

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Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2021.

Device User Fees for FY 2021

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Federal Register notice: FDA announces the fee rates and payment procedures for medical device user fees for fiscal year 2021.