In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers Guidance for Industry” (“2023 Draft Guidance”). The 2023 Draft Guidance supersedes previous draft guidance from 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“2014 Draft Guidance”), which was a revision of a 2009 final guidance entitled “Good Reprint ...
For the first time since 2008, the Advanced Medical Technology Association (“AdvaMed”) has updated its “Code of Ethics on Interactions with Health Care Professionals.” These updates were announced on January 9, 2019 and will become effective on January 1, 2020.
AdvaMed’s goal in updating the Code was to address the evolving nature of interactions between the medical device industry and health care professionals (“HCPs”), bring existing examples up-to-date, and enhance user-friendliness. Topics that were previously covered in multiple areas of the Code are now ...
- Podcast: Telehealth Post-Public Health Emergency – What to Expect in 2024 – Diagnosing Health Care
- Unpacking Averages: Analyzing FDA Device-Related Citizens Petitions by Topic
- Warning - Transaction Delays Expected. State Notice Requirements Ahead for Health Care M&A!
- New York Aims to Bolster Hospital Cybersecurity with Imminent Release of Proposed Regulations
- Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance