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Human Drugs

4 Observations in AnazaoHealth Inspection

FDA releases the form FDA-483 with four observations from an inspection at the Las Vegas, NV-based AnazaoHealth compounding facility.

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Human Drugs

FDAs Political Turn Risks Its Core Mission: Expert

FDA policy and regulatory expert Steven Grossman warns that the agencys current trajectory risks undermining its effectiveness by prioritizing politic...

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Human Drugs

Wisconsin Pharmacal CGMP Violations

FDA warns Jackson, WI-based Wisconsin Pharmacal about CGMP violations in its production of finished drugs.

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Biologics

FDA Waives Efficacy Studies for Stelara Biosimilar

FDA agrees to accept a biosimilar application to compete with Johnson & Johnsons Stelara that does not include clinical efficacy studies for a monoclo...

Medical Devices

Medtronic Gets FDA Green Light for Diabetes Devices

FDA clears a Medtronic 510(k) for its MiniMed 780G insulin delivery system to integrate with Abbotts Instinct continuous glucose monitoring sensor for...

Biologics

FDA Vaccines Panel Member Offit Removed

HHS says FDA is removing members of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and Childrens Hospital of Philadelphias V...

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Human Drugs

CGMP Issues at Compounders International

FDA warns Castle Rock, CO-based Compounders International Analytical Laboratory about CGMP violations and deviations in its work testing drugs and act...

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Human Drugs

FDA Publishes OTC Drug Monograph Forecast

FDA publishes the 2025 OTC drug monograph forecast showing eight items it expects to address over the next three years.

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Medical Devices

Hamilton Recalls Defective Coaxial Breathing Sets

Hamilton Medical recalls (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage...

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Biologics

Alzheimers Therapy Gets At-Home Injection Approval

FDA approves an Eisai/Biogen at-home injection option for Alzheimers treatment Leqembi (lecanemab), expanding access to patients in the early stages o...