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FDA Approves 1st Tysabri Biosimilar

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FDA approves a Sandoz BLA for Tyruko (natalizumab-sztn), the first biosimilar to Biogens Tysabri (natalizumab) injection for treat...

Finalized Informed Consent Guidance Analyzed

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Ropes & Gray attorneys break down a new FDA final guidance on informed consent, highlighting changes from a previous draft.

Objectionable Conditions in Clinical Investigation

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FDA warns Angela Stupi in Cranberry Twp., PA, about violations in her conduct of two trials with investigational drugs.

FDA Panel to Review Diabetes NDA Dispute

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Federal Register notice: FDA extends the comment period for a 7/14 notice that announced the availability of a draft guidance enti...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