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Sun Recalls 1 Batch of Doxorubicin HCl

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FDA says Sun Pharma has recalled one batch of doxorubicin HCl liposome injection due to glass particles found in some vials during...

FDA May be OK Under Loper Bright: Article

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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 ...

CDER Impurity Acceptance Criteria MAPP

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CDER publishes a Manual of Policies and Procedures on approaches for assessing drug substance and drug product impurity acceptance...

FDA in Turmoil as Critics Across Washington Pile On

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FDA commissioner Marty Makarys resignation capped one of the shortest and most turbulent FDA tenures in recent memory, with media ...

Positive Data with Imfinzi Regimen in Bladder Cancer

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AstraZeneca reports positive data in a trial evaluating perioperative treatment with Imfinzi (durvalumab) combined with neoadjuvan...

Petition Urges Actions Against Weight Loss Device

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A citizen petition urges FDA to take enforcement action against the BariClip, an implantable bariatric device that petitioners say...

Add Warning to OTC Acetaminophen Product Labels: Petition

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Americans for Scientific Integrity asks FDA to add reproductive development warnings and use instructions to labeling for over-the...

FDA Issues Guide on Long-Acting Local Anesthetics

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FDA posts a draft guidance outlining recommendations for drugmakers developing local anesthetic products designed to provide prolo...

AEMS May Mean Increased Stakeholder Scrutiny: Column

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Three Morgan Lewis attorneys say companies regulated by FDA should prepare for increased scrutiny due to near-real-time data being...

FDA Publishes 2 Analgesic Draft Guidances

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FDA publishes draft guidances on developing non-opioid analgesics for chronic pain and facilitating a benefit/risk analysis for op...