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Radiopharmaceutical drug manufacturers say they need more consistency from FDA in inspections and regulatory operations.[ Price : $8.95]
The U.S. Supreme Court hands a victory to Hikma Pharmaceuticals in a closely watched case testing the patent risks of FDA-approved...[ Price : $8.95]
FDA posts a guidance outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification req...[ Price : $8.95]
A Friends of Cancer Research white paper recommends three ways the FDA Biomarker Qualification Program could be improved.[ Price : $8.95]
U.S. House lawmakers introduce bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechno...[ Price : $8.95]
Former FDAers Richard Pazdur and Nicole Gormley promote ways to restructure the agency so it can be more independent and successfu...[ Price : $8.95]
FDA acting commissioner Kyle Diamantas, who is rumored to be under consideration to be named commissioner, meets with rare disease...[ Price : $8.95]
The Senate Special Committee on Aging hears testimony on how an unsecure U.S. drug supply chain is harming older patients.