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Medical Devices

AdvaMed Comments on Electronic Submission Guide

AdvaMed raises concerns about an FDA draft guidance on De Novo electronic submissions.

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Human Drugs

Concerns About FDA QMM Program

The Association for Accessible Medicines raises several issues and concerns with FDAs proposal to develop a quality management maturity program.

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Marketing

Durbin, Grassley Push Drug Ad Transparency Bill

Sen. Mike Crapo blocks an attempt by Sens. Dick Durbin and Charles Grassley to get unanimous consent to approve their bipartisan drug ad price disclos...

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Biologics

Regenerative Medicine Consensus Standards Guide

FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.

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Human Drugs

Similar Intas CGMP Violations

FDA warns Intas Pharmaceuticals about repeat CGMP violations at its drug manufacturing facility in Matoda-Sanand, Ahmedabad, India.

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Federal Register

Korsuva Regulatory Review Period

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cara Therapeutics Korsuva (difelikefalin acetat...

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Federal Register

Cosela Regulatory Review Period

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for G1 Therapeutics Cosela (trilaciclib), indicate...

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Federal Register

Info Collection on Device Shortages Data

Federal Register notice: FDA seeks comments on an information collection extension entitled Shortages Data Collections.

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Human Drugs

Serious Reaction to Some Anti-Seizure Meds: FDA

FDA warns of a rare but serious risk of Drug Reaction with Eosinophilia and Systemic Symptoms associated with two anti-seizure drugs.

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Human Drugs

Acelyrin Auditing Izokibep Trial Issues

Acelyrin says it will have an independent auditor evaluate contractor research organization issues in trials for its izokibep.