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Human Drugs

Boebert Bill to Ease Botanical Drug Development

Rep. Lauren Boebert introduces legislation to remove some barriers to the development of botanical drugs.

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Human Drugs

Support, Suggestions for Expedited IND Pilot

Five stakeholders support an FDA proposal for an expedited IND pilot program and suggest ways to improve it.

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Marketing

FDA Promotion Crackdown Enters New Phase: Attorneys

Attorneys from Arnall Golden Gregory examine and offer advice on FDAs intensified scrutiny of drug advertising, advising companies to prepare for clos...

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Human Drugs

Senate Report Raises Questions About Oversight of Mifepristone Providers

A new report from Senate HELP chair Bill Cassidy (R-LA) targets FDA for allowing the abortion drug mifepristones Risk Evaluation and Mitigation Strate...

Human Drugs

PDUFA 8 Commitment Letter Analyzed

Akin Gump attorneys highlight major issues in the PDUFA 8 commitment letter that is now open for public comment.

Medical Devices

QMSR Finding Single Risk Thread: Report

MasterControl issues its 2026 life sciences regulatory readiness playbook demonstrating the significant ways in which the FDA Quality System Managemen...

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Human Drugs

Court Upholds FDA Shortage Resolution Decision on Lillys Tirzepatide

The U.S. Court of Appeals for the Fifth Circuit upholds FDAs decision to remove tirzepatide from the agencys drug shortage list, a ruling that limits ...

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Human Drugs

Courts Rejecting Loper Arguments in Product Liability: Attorney

Reed Smith attorney James Beck says courts so far have rejected all arguments citing the Supreme Courts Loper Bright decision as a reason to reject pr...

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Human Drugs

Celcuity Files sNDA for Revtorpyk Expanded Use

Celcuity files a supplemental NDA for Revtorpyk (gedatolisib) for treating certain patients with hormone receptor positive, human epidermal growth fac...

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Human Drugs

FDA OKs RevMeds Promising Pancreatic Cancer Drug

FDA approves Revolution Medicines Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer.