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FDA Panel to Review Diabetes NDA Dispute

[ Price : $8.95]

FDA says its Endocrinologic and Metabolic Drugs Advisory Committee will meet 9/21 to review and vote on an Intarcia Therapeutics N...

Regulate Cannabis Under Existing Law: CFCR

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The Council for Federal Cannabis Regulation says FDA should use its enforcement discretion to regulate cannabis products now while...

FDA Warning on Dr. Bernes Eye Drops

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FDA issues a warning against using Dr. Bernes MSM Drops 5% Solution and LightEyez MSM Eye Drops Eye Repair due to bacterial or fu...

Comments Extended on Cell, Gene Therapies

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Federal Register notice: FDA extends the comment period for a 7/14 notice that announced the availability of a draft guidance enti...

Workshop on Clinical Study Diversity

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Federal Register notice: FDA announces an 11/29-30 public workshop entitled Workshop to Enhance Clinical Study Diversity.

Draeger Recalls Carina Ventilators

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Draeger Medical recalls its Carina Sub-Acute Care Ventilators due to the presence of contaminants in the devices airpath.

Dingell Concerned About TB from Bone Grafts

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Rep. Debbie Dingell asks FDA and CDC to answer questions about recent cases of tuberculosis linked to contaminated Aziyo Biologics...

Changes Sought in FDA Diabetes Endpoint Guidance

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Three stakeholders make suggestions to an FDA draft guidance on efficacy endpoints in clinical trials for antidiabetic drugs.

Lillys Retevmo Hits Phase 3 Trial PFS Endpoint

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Lilly says its Retevmo met the primary progression-free survival endpoint in a clinical trial in patients with RET-mutant medullar...

Welldoc Insulin Dose Calculator Clearance

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FDA clears a Welldoc 510(k) for its BlueStar diabetes digital health device that provides bolus insulin dose recommendations based...