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FDA Seeks New Authorities for Drug Supply Chain Integrity

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A Senate hearing examines new authorities FDA could use to help it protect the U.S. drug supply chain.

FDA Clears Bone Fixation Device

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FDA clears an Internal Fixation Systems 510(k) for its bone fixation devices that include various plates, screws, and washers used...

FDA Consent Decree Blocks Sale of Amino Acid Products

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FDA signs a consent decree of permanent injunction with CHK Nutrition and NeuroResearch Clinics under which the companies agree to...

FDA Makes Revimmune Orphan Drug

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FDA approves orphan drug status for Accentia Biopharmaceuticals Revimmune for preventing graft-versus-host disease.

FDA Advisors Recommend Ferriprix Accelerated Approval

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FDAs Oncologic Drugs Advisory Committee recommends that FDA give accelerated approval to ApoPharmas Ferriprox.

Better Animal Antibiotic Data Collection Needed: GAO

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The Government Accountability Office says HHS and USDA need to do better data collection on animal antibiotic use to be able to ev...

CGMP Violations Found at Lonza Biologics

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FDAs New England District Office warns Lonza Biologics about CGMP violations in its manufacture of finished pharmaceuticals and ac...

Luitpold Warned About CGMP Problems

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FDAs New York District Office warns Luitpold Pharmaceuticals about CGMP violations at its drug manufacturing facility.

Advanced Bionics Reintroducing Troubled Cochlear Implant

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Advanced Bionics gains FDA approval to reintroduce into the market its HiRes 90K cochlear implant that was recalled last year due ...

FDA Should Tighten Approval Standards on Transplant Drugs: Editorial

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A medical journal editorial calls on FDA to tighten its approval criteria for generic immunosuppressive drugs.