Happy New Year! On January 1, 2022, the recently revised version of the PhRMA Code on Interactions with Health Care Professionals went into effect. We summarized the major revisions to the Code in a blog post when it was released in August 2021. Many of the …
As we approach our third year of COVID, one of the major questions from March 2020 eerily echoes today: where are all the COVID tests? The situation now, of course, is very different and much more favorable than two years ago. Unlike March 2020, numerous …
On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). Computational modeling and simulation (CM&S) can sometimes be useful to demonstrate the safety and effectiveness of medical devices or incorporated into …
