Analysis: Is the Trump Administration Eroding Trust in the FDA? - Government Executive

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Read the full source article:  Analysis: Is the Trump Administration Eroding Trust in the FDA? - Government Executive

According to the article:

"The FDA has spent decades establishing a science-based framework for rigorously reviewing products and must be allowed to apply it without political interference, said Ledley. “I’m not confident this will happen,” he added. Neither are seven former FDA commissioners who, in an op-ed for The Washington Post, expressed concern that the Trump administration’s fingerprints were all over FDA decision making — not just in encouraging the agency to promote unproven treatments, but also in curbing its rule-making authority and trying to rush approval of a vaccine. Those politically motivated actions, they argued, are eroding the public’s confidence in any vaccines that gain approval — and public health authorities in general."

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Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

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Read the full article:   Replacement of Title 21 CFR Part 820 with ISO 13485-2016 - Clarkston Consulting

According to the article:

"The FDA originally published a Notice of Proposed Rule Making (NPRN) in May 2018. The abstract from Regulation Identifier Number (RIN) 0910-AH99 states: “FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufactures, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.” The NPRM is currently at the Proposed Rule Stage with an action date in October 2020. A panel committee meeting will be held after issuance of the proposed rule."

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