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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles. By Adrienne R.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law Blog

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

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DEA Cranks Out Updated Special Surveillance List and Proposed Regulatory Actions

FDA Law Blog

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.