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Comments Reopened on Opioid Disposal

[ Price : $8.95]

Federal Register notice: FDA reopens the comment period for the 4/4 notice entitled In-Home Disposal Systems for Opioid Analgesics...

FDA Dismisses Novo Nordisk Inspection Concerns

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In an unusual move, FDA issues a statement about recent agency inspections at Novo Nordisks Clayton, NC manufacturing facility to ...

Emergency Clinical Trial Conduct Guidance

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Federal Register notice: FDA makes available a final guidance entitled Considerations for the Conduct of Clinical Trials of Medica...

MicroVention Transradial Access Catheter Cleared

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FDA grants Terumos MicroVention unit 510(k) clearance for its SOFIA EX 5F 115 cm intracranial support catheter for transradial acc...

Major Disruption Clinical Trial Guidance

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FDA publishes a guidance to assist those involved with clinical trials in determining how to proceed during a disaster or public h...

Industry Fights FDA on Drug Shortage Fixes: Califf

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FDA commissioner Robert Califf tells a podcast that drug manufacturers have fought FDA efforts to encourage companies to produce m...

FDA Reviewers Again Nix Intarcia Diabetes Product

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FDA medical reviewers tell the Endocrinologic and Metabolic Drugs Advisory Committee that they believe the Intarcia NDA for its IT...

Drug Preemption Defense Demanding, Attainable: Attorneys

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Two attorneys say their review of drug preemption cases shows that the defense is demanding but can be attained.

Disc Medicine Gets Fast Track for MWTX-003

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FDA grants Disc Medicine a fast-track designation for MWTX-003 and its use for treating patients with polycythemia vera.

Relmada Depression Trial Shows Promise

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Relmada Therapeutics says a Phase 3 trial in Major Depressive Disorder shows that patients treated daily with REL-1017 for up to o...