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No Walk in the Park: JAMA Editorial Calls for More Park Prosecutions; We Disagree

FDA Law

While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree. The JAMA editorial notes that there are few Park cases for two primary reasons: [The government] may lead.

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FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. The regulatory uncertainty has ill?befitted Part 807, Subpart E). The new rule will be codified in 21 C.F.R.

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Writing for the Lay Public: Rosanne Leipzig and Louise Aronson

GeriPal

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. Louise: Well again, if you take that approach, you also get rid of ableism and ageism against children and prejudice against people who are ill. But I was focused on his very ill wife. So sometimes I don’t write.

IT 105