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FDA General

Overton Pledges Science-Based FDA Decisions at Confirmation Hearing

FDA commissioner nominee Heidi Overton pledges to accelerate drug development, strengthen regulatory oversight and preserve the agency's scientific in...

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Medical Devices

Robotically Assisted Surgical Devices Guidance

FDA issues a draft guidance on premarket submissions for robotically-assisted surgical devices and announces a public workshop.

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Human Drugs

Lillys Once-Weekly Insulin Injection Approved

FDA approves Eli Lillys Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for controlling high blood sugar in adults with Typ...

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Human Drugs

FDA Approves Advanced Renal Cell Cancer Treatment

FDA approves a combination of Mercks Welireg and Eisais Lenvima to treat some patients with renal cell carcinoma with a clear cell component.

Human Drugs

Boxed Warning for Adzynma Enzyme Replacement

FDA directs Takeda to add a Boxed Warning to the labeling for its Adzynma enzyme replacement therapy for congenital thrombotic thrombocytopenic purpur...

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Human Drugs

3 Observations in STAQ Pharma Inspection

FDA releases the Form FDA-483 with three observations from its inspection at the Columbus, OH-based STAQ Pharma Ohio outsourcing facility.

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Biologics

CBER Sponsor Regulatory Meetings SOPP

CBER issues a Standard Operating Policy and Procedure on scheduling and conducting regulatory meetings on drugs and biologics.

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FDA General

FDA Consent Decree Against Gold Star Distribution

A federal court has entered a consent decree of permanent injunction against Gold Star Distribution, Inc., prohibiting the Minnesota warehouse operato...

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Biologics

Are Comparative Clinical Studies of Biologics Worth the Time and Cost?

FDA says a meta-analysis performed by CDER scientists suggests that pharmacokinetic similarity studies can often yield sufficient information on biosi...

Medical Devices

Multiple Types of Violations at Specialty Health Products

FDA warns Phoenix, AZ-based Specialty Health Products about multiple violations in its marketing of unapproved colonic irrigation systems.