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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...

Brukinsa TV Ad False or Misleading: OPDP

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A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine TV spot for its leukemia drug B...

Despite Makary Leaving, Industry Could Feel Pressure: Analysis

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Analysts and investors interviewed by Reuters see a short-term positive reaction to the departure of Marty Makary, but caution tha...

Guidance Signals Broader Public Health Scrutiny for New Opioids

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FDA releases a draft guidance detailing how the agency will evaluate the benefits and risks of new opioid analgesic drugs, emphasi...

Inspection Pilot May be Permanent as FDA Expands AI-Driven Oversight

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A King & Spalding legal analysis examines FDAs newly announced pilot program for one-day inspectional assessments, suggesting it m...

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FDA posts a draft guidance outlining recommendations for drugmakers developing local anesthetic products designed to provide prolo...

Israeli Firm Selling Adulterated Unapproved Drugs Online: FDA

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FDA warns Israels Naveh Pharma and Atlanta, GA-based Bigdam about selling unapproved new drugs that are adulterated by CGMP violat...

FDA Commissioner Makary Resigns After Administration Pressure

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FDA commissioner Marty Makary hands in his resignation after a week of mounting speculation that the Trump Administration was prep...

Clarify Draft on FDA-483 Responses: Comments

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Stakeholders ask FDA to clarify its draft guidance on responses to an FDA-483.