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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...

Leo Pharma Gets Updated Prescribing Info for Enstilar

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FDA approves a Leo Pharma supplemental NDA for updated prescribing information for Enstilar (calcipotriene and betamethasone dipro...

FDA Posts Quarterly FAERS Risk Signal Report

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FDA posts the second quarter 2020 list of potential signals of serious risks or new safety information for drugs identified throug...