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Radiopharmaceutical Companies Want FDA Consistency

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Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations.

Supreme Court Sides With Generics in Skinny Label Dispute

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The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved...

FDA Plans to Exempt Low-Risk Devices From 510(k) Requirements

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FDA posts a guidance outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification req...

Ways to Improve Biomarker Qualification

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A Friends of Cancer Research white paper recommends three ways the FDA Biomarker Qualification Program could be improved.

Bipartisan Bill to Curb Investment in Chinas Biotech Sector

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U.S. House lawmakers introduce bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechno...

Pazdur Recommends Restructuring FDA

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Former FDAers Richard Pazdur and Nicole Gormley promote ways to restructure the agency so it can be more independent and successfu...

Diamantas Tries to Win Back Rare Disease Advocates

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FDA acting commissioner Kyle Diamantas, who is rumored to be under consideration to be named commissioner, meets with rare disease...

Faulty Drug Supply Chain Hurts Seniors: Hearing

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The Senate Special Committee on Aging hears testimony on how an unsecure U.S. drug supply chain is harming older patients.

FDA Accepts 1st Drug-Induced Liver Injury Tool

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FDA has accepted a Letter of Intent for the first in silico artificial intelligence-driven digital liver model for predicting drug...

FDA Accepts Roche NDA for Breast Cancer Drug

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FDA accepts for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy for patients with early-st...