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QS Violations Found in A-1 Engineering Inspection

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FDAs Los Angeles District Office warns A-1 Engineering about Quality System violations in its manufacturing and distribution of tw...

Researchers Propose Orphan Drug Regulatory Reforms

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Researchers from Johns Hopkins say the Orphan Drug Act needs to be reformed to prevent pharmaceutical companies from gaming the sy...

CDRH to Complete Essure Safety Review in February

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CDRH says it will complete a safety review of Bayer Healths controversial Essure permanent birth control device by the end of Febr...

State Versus Federal Drug Rule in 2 Court Cases

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New York University law professor Catherine Sharkey describes two recent court cases that explore the tension between federal and ...

PDUFA 6 Sub-groups Report

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Five PDUFA 6 Reauthorization Steering Committee sub-groups report on their discussions and progress at the 10/20 steering committe...

IRB Minutes Guidance Explained

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Four Quarles & Brady attorneys summarize provisions of a new FDA guidance on institutional review board minutes.

CGMP Violations at Two Sandoz India Plants

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FDA warns Sandoz Private Limited about CGMP problems found at two drug manufacturing facilities in India.

Another Senator Opposes Califfs Nomination

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U.S. senator Lisa Murkowski (R-AK) says she will oppose Robert Califfs nomination to become the next FDA commissioner due to the a...

FDA Releases Dr. Reddys Warning Letter

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FDA releases its 11/5 Warning Letter to Dr. Reddys Laboratories detailing findings from inspections at three of the companys facil...

FDA Guidance on Medical Gas Certification Under FDASIA

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FDA posts a draft guidance on Certification Process for Designated Medical Gases that explains how the agency administers the cert...