FDA Law Blog
JUNE 28, 2021
On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. 151.066, Subd.
The Clinical Problem Solvers
DECEMBER 16, 2020
Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. 2019 Jun 25;73(24):3234]. J Am Coll Cardiol. 2019;73(24):3153-3167. doi:10.1016/j.jacc.2018.11.005 2018.11.005 Hoffman KM, Trawalter S, Axt JR, Oliver MN.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
MAY 8, 2023
Although FDORA gave FDA express authority to allow PCCP , FDA had already been considering creating a mechanism for manufactrurers to prespecify modifications for AI/ML-based software subject to 510(k) premarket notification and de novo classification for several years.
FDA Law Blog
JUNE 23, 2021
For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature). By Asking Them.
FDA Law Blog
JULY 10, 2023
Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Average Number of Industry Days to MDUFA IV Decision 54.69
GeriPal
NOVEMBER 9, 2023
The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. ” Eric: It strikes me that there also seems to be a difference between coaching a team, like many of us are familiar with, and this individual coaching, although there may be group coaching as well. We learn in context.
Annals of Family Medicine
NOVEMBER 20, 2024
This specialized workforce has not yet been classified in health administrative data, limiting our understanding of their individual and medical practice characteristics. Study design and setting: Retrospective cohort study using multiple population-based health administrative datasets in Ontario, Canada in 2019.
Expert insights. Personalized for you.
52 
Let's personalize your content