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Pharmaceutical Industry › Food and Drug Administration (FDA) › Inspection Rights

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FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

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On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment. ...more

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FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

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Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more

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FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

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Earlier yesterday, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance...more

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Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

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On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

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