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Federal Register

FDA Updates Compliance Program for Biologic Drug Manufacturers

FDA issues an updated compliance program that standardizes how inspectors evaluate manufacturing facilities tied to biologic drug applications.

Human Drugs

CGMP Violations Found at Medical Products Laboratories

FDA warns Philadelphia, PA-based Medical Products Laboratories about CGMP violations in its manufacturing of unapproved new drugs.

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Human Drugs

Multiple Issues in Purolea Cosmetics Lab Inspection

FDA warns Livonia, MI-based Purolea Cosmetics Lab about CGMP and other violations in its production of finished drugs as a contractor.

Medical Devices

Dont Underestimate Device Quality System Inspection Changes: Column

Medical device regulation expert Adrienne Lentz describes the highlights from a 4/2 FDA Quality Management System Regulation town hall.

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Human Drugs

Guidance on Sequencing Standards for Genome Editing Therapies

FDA posts a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing.

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Human Drugs

Exelixis Wants 505(b)(2) Cabometyx Restrictions

Exelixis petitions FDA to require Handa Pharmaceuticals and others submitting a 505(b)(2) NDA for a caboztinib product referencing Exelixis Cabometyx ...

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Human Drugs

FDA Form 483 Response Guidance Outlined

Three McDermott attorneys outline the key elements in an FDA 3/2026 guidance that helps establishments respond to an FDA-483.

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Human Drugs

Quality, Data Integrity Issues Flagged at Indian API Maker Hikal

FDA cites significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the companys active pharmaceutic...

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Human Drugs

Traveres Filspari Approved for Rare Kidney Disease FSGS

FDA approves Travere Therapeutics Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis.

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Human Drugs

Bioanalytical Method Validation for Biomarkers Guidance

FDA publishes a guidance titled "Bioanalytical Method Validation for Biomarkers to help sponsors to validate bioanalytical methods used to evaluate bi...