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Human Drugs

U.S. Drug Shortages Increasing: Report

An Iqvia Institute report says drug shortages continue to increase in the U.S., with the number of new shortages outpacing the number resolved.

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Human Drugs

Provide Covid Therapeutics Distribution Info: Califf

FDA commissioner Robert Califf calls on the Healthcare Distribution Alliance to give aggregate information to the agency on the distribution of Covid ...

FDA General

2 Consent Decrees Against Supplement Marketers

The central Utah federal court approves two consent decrees of permanent injunction against Evig LLC and Premium Production LLC over their distributio...

Human Drugs

SpringWorks Filing Mirdametinib NDA in 2024

After releasing promising clinical data, SpringWorks Therapeutics says it will file an NDA in the first half of 2024 for mirdametinib, an investigatio...

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Human Drugs

Janet Woodcock Retiring in Early 2024

FDA principal deputy commissioner Janet Woodcock announces she is retiring early next year after 37 years at the agency.

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Medical Devices

Managing Legacy Device Cyber Risks

An FDA-funded report makes recommendations for improving the cybersecurity of legacy medical devices.

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Product Testing Alternative Methods

A new FDA Web page highlights agency efforts to research and implement alternative methods for product testing.

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Human Drugs

CGMP Violations in Turkish OTC Drug Manufacturer

FDA warns Tekirdag, Turkey-based Saruhan Kimya Va Temizlik Urunieri Sanayi Ticaret Anonim Sirketi Corlu Subesi about CGMP violations in its production...

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Human Drugs

Orphan Status for Lymphoma Therapy

FDA grants SIRPant Immunotherapeutics an orphan drug designation for SIRPant-M, an autologous macrophage therapy for treating T-cell lymphoma.

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Human Drugs

FDA Punts Merck Cough Drug Data to Panel

FDA reviewers say that making an assessment on the clinical meaning of complicated data presentations in a Merck NDA resubmission for chronic cough me...