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University of Missouri law professor Erika Lietzan says FDA may not suffer as much under the Supreme Courts Loper Bright decision ...[ Price : $8.95]
CDER publishes a Manual of Policies and Procedures on approaches for assessing drug substance and drug product impurity acceptance...[ Price : $8.95]
FDA commissioner Marty Makarys resignation capped one of the shortest and most turbulent FDA tenures in recent memory, with media ...[ Price : $8.95]
AstraZeneca reports positive data in a trial evaluating perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvan...[ Price : $8.95]
A citizen petition urges FDA to take enforcement action against the BariClip, an implantable bariatric device that petitioners say...[ Price : $8.95]
Americans for Scientific Integrity asks FDA to add reproductive development warnings and use instructions to labeling for over-the...[ Price : $8.95]
FDA posts a draft guidance outlining recommendations for drugmakers developing local anesthetic products designed to provide prolo...[ Price : $8.95]
Three Morgan Lewis attorneys say companies regulated by FDA should prepare for increased scrutiny due to near-real-time data being...