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Multiple Violations at Onkos Surgical

[ Price : $8.95]

FDA warns Parsippany, NJ-based Onkos Surgical about Quality System and Medical Device Reporting violations in its work as a medica...

CGMP Deviations in Macsen Drugs Inspection

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FDA warns Indias Macsen Drugs about CGMP deviations in its production of active pharmaceutical ingredients.

J&J Seeks Label Update on Tremfya

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Johnson & Johnson files a supplemental BLA seeking to update the prescribing information for Tremfya (guselkumab) to include new d...

FDA Ratchets Up Heat on 7-OH Products

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FDA recommends placing 7-hydroxymitragynine (7-OH) a highly concentrated, synthetic byproduct of the kratom plant under the Contr...

Shiva Contract Lab CGMP Violations

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FDA warns Indias Shiva Analyticals Private Limited about CGMP violations in its work as a contract testing laboratory.

Quality Management Benefits Exceed Costs: FDA Paper

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The CDER Office of Pharmaceutical Quality publishes a white paper making the economic case for quality management practices.

Antibacterial Therapies Q&A Guidance

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FDA issues a question-and-answer guidance on the development of certain antibacterial therapies.

PTC Therapeutics Phenylketonuria Drug Approved

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FDA approves a PTC Therapeutics NDA for Sephience (sepiapterin), indicated for treating adult and pediatric patients with phenylke...

User Fee Rates Set for FY 2026

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FDA posts the user fee rates for fiscal year 2026 for prescription drugs and biologics, biosimilar, medical devices and generic dr...

Guide on Aluminum Content in Parenteral Drugs

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FDA issues a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral...