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Acer NDA for Urea Cycle Disorders

[ Price : $8.95]

FDA accepts for review an Acer Therapeutics NDA for Acer-001 sodium phenylbutyrate) for treating patients with urea cycle disorder...

FDA Fetal Pharmacology and Therapeutics Workshop

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FDA announces a 10/21-10/22 virtual workshop on fetal pharmacology and therapeutics.

ICH Carcinogenicity Testing Supplement Out

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FDA publishes an International Council on Harmonization addendum expanding testing methods for human carcinogenicity risk studies....

Drug Compounding Issues at The Medicine Shoppe

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FDA warns The Medicine Shoppe in Port Charlotte, FL, that it is producing compounded drugs that dont meet legal requirements and d...

Advisors Considering Data from 2 Maribavir Trials

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FDA medical reviewers raise issues with two trials of Takedas maribavir to treat cytomegalovirus.

Takeda Pharma Stops 2 TAK-994 Studies

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Takeda Pharmaceutical Co. stops two Phase 2 studies of TAK-994, an investigational oral orexin agonist for treating narcolepsy, a...

Guide on Animal Drug Adaptive Trials

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Federal Register notice: FDA makes available a guidance entitled #268 Adaptive and Other Innovative Designs for Effectiveness Stud...

FDA Promotes New Approaches to Animal Drug Approval

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FDA publishes four final guidances encouraging new sponsors of new animal drugs to pursue innovative ways to prepare and submit da...

Guide on Drug Carcinogenicity Testing

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Federal Register notice: FDA makes available a draft guidance entitled S1B(R1) Addendum to S1B Testing for Carcinogenicity of Phar...

Marci Beauty Selling Unapproved Light Therapy Devices: FDA

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FDA warns Marci Beauty it is marketing seven unapproved light therapy devices.