Manufacturing, Presentation, Screening and Specialization

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

NOVEMBER 20, 2024

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.

Provider

Provider Medical Manufacturing Consulting

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Alex 00:59 And I met all three of you and watched you do a presentation about psilocybin research at the Congress International Desens Palliative Miguel. So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. Ali John, welcome to the GeriPal Podcast.

Illness

Illness IT Patient-Centered Patients

Primary Care Digest

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

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