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Clinical Investigation Didnt Follow Plan: FDA

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FDA warns Anish Shah, doing business as Siyan Clinical Research in Santa Rosa, CA, about not following the investigational plan fo...

Update on FDA Real-World Evidence Activities

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FDA commissioner Robert Califf says the agency recently published three additional guidances to help advance the use of real-world...

Real-World Data Registries Guidance

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FDA publishes a guidance on assessing registries to support drug and biologic regulatory decision-making as part of its real-world...

ResMed Updates Labeling for Masks with Magnets

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FDA says ResMed has issued updated instructions for its masks with magnets to inform users about potential magnetic interference w...

Rare Disease Drug Development Guidance

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FDA publishes a guidance to assist sponsors in conducting efficient and successful drug development programs to treat rare disease...

Drug Development Master Protocol Guidance

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FDA publishes a draft guidance making recommendations on the design and analysis of drug development trials conducted under a mast...

Updated Labeling for Promethazine HCl

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FDA requires updated labeling for promethazine HCl injection to recommend administration through deep intramuscular rather than in...

Cell/Gene Product Potency Assurance

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FDA publishes a draft guidance on developing a science- and risk-based strategy to help assure the potency of a human cellular the...

CGMP Violations at Patco Cosmetics

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FDA warns Indias Patco Cosmetics about CGMP violations in its manufacturing of finished over-the-counter drugs.

Dont Use Counterfeit Ozempic: FDA

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FDA says it has seized thousands of units of counterfeit Ozempic that also contain counterfeit needles.