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FDA Cites Aurobindo for Drug Supply Security Lapses

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FDA cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including del...

AVID Medical Recalls Organ Recovery Bags

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AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits.

Fast Track for Alessas Prostate Cancer Therapy

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FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.

FDA Guide Outlines Expectations for Bayesian Trial Designs

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A new FDA guidance details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to s...

FDA Flags Deficiencies in Aquestives Anaphylm NDA

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FDA tells Aquestive Therapeutics that deficiencies have been identified in the companys NDA for Anaphylm that currently preclude l...

FDA Accepts Camurus NDA Resubmission for Acromegaly Drug

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FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a once-monthly treatment for acromegaly.

Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

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A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Squibbs Karuna Therapeutics unit u...

FDA Flags BeOne Tevimbra Promotional Materials

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CDERs Office of Prescription Drug Promotion sends BeOne Medicines USA an untitled letter over its promotional materials for cancer...

PDUFA 8 Negotiations on RWE, First-Cycle Reviews

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Representatives of FDA and the drug industry make progress in PDUFA 8 discussions on real-world evidence and metrics for first-cyc...

Harvard Law Hits User Fees Over Corporate Capture

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A new analysis from Harvard Law School argues that the U.S. drug regulators reliance on industry-paid user fees has left the agenc...