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Susceptibility Test Interpretive Criteria Updates

[ Price : $8.95]

Federal Register notice: FDA makes available an annual compilation of updates to the agencys Susceptibility Test Interpretive Crit...

FDA Greenlighting AZ Covid Vaccine Restart: Report

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Reuters says FDA is ready to authorize AstraZeneca to resume its U.S. trial of a Covid-19 vaccine that has been on hold since 9/6 ...

FDA Awards $1.1 Million Immunoinformatics Contract

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FDA awards a $1.1 million contract to EpiVax and CUBRC to continue its work on evaluating generic peptide drugs and their impuriti...

Wholesale Distributor Verification Enforcement Off till 2023

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FDA issues a compliance policy guidance delaying for three additional years enforcement of a provision for wholesale distributors ...

Azar Planning to Dump Hahn: Politico Report

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Politico reports, based on anonymous sources, that HHS secretary Alex Azar is opening plotting to remove FDA commissioner Stephen ...

Guidance Delays Drug Supply Chain Security Enforcement

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An FDA final guidance delays the enforcement of certain Drug Supply Chain Security Act requirements.

Nonclinical Study Data eSubmission Pilot

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Federal Register notice: FDA announces that it intends to conduct a fit-for-use pilot program to test the processing and analysis ...

Avioq HIV Profile Supplemental Assay Approved

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FDA approves Avioqs VioOne HIV Profile Supplemental Assay, an enzyme-linked immunosorbent assay for confirmation and differentiati...

FDA Approves Gileads Remdesivir for Covid-19

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FDA approves a Gilead Sciences NDA for Veklury (remdesivir), indicated for treating patients with Covid-19 that requires hospitali...

Cala Health Get Breakthrough Status for Hand Tremors

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FDA grants Cala Health a breakthrough device designation for its Cala Trio targeted therapy for treating action tremors in the han...