FDA Law Blog

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

MAY 27, 2024

She also specializes in medical device software and digital health. Jennifer’s return adds depth and breadth to our device practice and her strong relationships from her earlier time at the firm has made for a seamless reentry,” said J.P. Jennifer also helps clients with contract matters, regulatory due diligence, and public filings.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

FDA Law Blog

MAY 7, 2025

Seventh Circuit ruling in Sorensen In Sorensen , the government alleged, and the District Court agreed, that Sorensen paid illegal kickbacks to marketing firms based on the number of leads generated and a DME manufacturer based on the percentage of funds collected from Medicare.

Referral 59

Referral Relationship Government Healthcare 59

GeriPal

MAY 8, 2025

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. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? James 01:34 Yeah, right on.

Illness 109

Illness IT Patient-Centered Patients 109

GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. And so if we think of that relationship though, as these kinds of disasters increasing, so flooding, hurricanes, extreme heat and extreme cold, there are system level things to do.

Healthcare 130

Healthcare IT Education Community 130