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Antibacterial Therapies Development Q&A Guidance

[ Price : $8.95]

FDA publishes a question-and-answer guidance to help sponsors develop new antibacterial drugs.

Altimmune Mixed Results for Pemvidutide in MASH

[ Price : $8.95]

Altimmune reports mixed topline results today from its Phase 2b IMPACT trial evaluating pemvidutide in patients with metabolic dys...

UDI Requirements for Combo Products Guide

[ Price : $8.95]

FDA posts a draft guidance entitled Unique Device Identifier (UDI) Requirements for Combination Products.

Marks: Why Dramatic Departure from Vaccine Policy?

[ Price : $8.95]

Former CBER director Peter Marks says FDA should explain why it changed its Covid-19 vaccine policy in a way that did not promote ...

Remote Regulatory Assessment Q&A Guidance

[ Price : $8.95]

FDA publishes a guidance with questions and answers on its various remote regulatory assessment tools.

Device Cybersecurity Quality System Consideration Guide

[ Price : $8.95]

FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submi...

FDA RMAT Designation for Detalimogene

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FDA grants regenerative medicine advanced therapy designation for enGene Holdings bladder cancer drug detalimogene.

Viatris Plans NDA for MR-141 in Presbyopia

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Viatris plans to submit an NDA later this year for phentolamine ophthalmic solution 0.75% for treating presbyopia based on just-re...

Sterling Drug Supply Chain Violations

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FDA warns Sterling Distributors about its multiple violations of the Drug Supply Chain Security Act.

Guide on Developing Drugs for Lyme Disease

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FDA posts a final guidance entitled Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.