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Off-Label Communications Q&A Guide

[ Price : $8.95]

FDA issues a guidance finalizing a 2023 draft document on communicating scientific information on unapproved uses of approved or c...

Rybrevant/Lazcluze Cancer Study Positive: J&J

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Johnson & Johnson says its Phase 3 MARIPOSA study showed that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a st...

Jiao Debarment Notice Corrected

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Federal Register notice: FDA corrects a 12/5/2024 debarment notice against Yong Sheng Jiao (also known as Yongsheng Jiao and Wilso...

2 ALS Drugs Miss Endpoints

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Denali Therapeutics and Calico Life Sciences say their two eukaryotic initiation factor 2B activator drugs each failed to meet pri...

Lifecycle Recommendations for AI-Enabled Devices

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FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical devic...

Sex Differences in Clinical Evaluations of Products

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FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.

RSV Vaccines Get Guillain-Barr Warning

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FDA requires safety labeling changes about Guillain-Barr syndrome risks for Pfizers Abrysvo (respiratory syncytial virus vaccine) ...

Ionis Spinraza Approved by FDA for SMA

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FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.

Guide on Device Supply Interruption Notifications

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FDA posts a final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under...

Guide on Seeing if Confirmatory Study Underway

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FDA issues a draft guidance entitled Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Under...