FDA Law

JANUARY 4, 2022

Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code.

Manufacturing 98

Manufacturing Specialization IT 98

FDA Law

OCTOBER 3, 2022

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. Mr. Bawduniak claimed that these events were held at “sumptuous resorts and restaurants” and involved “lavish meals and free alcohol.” Bawduniak v.

Consulting 105

Consulting Healthcare Professional Specialization Government 105

FDA Law

AUGUST 23, 2021

Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ).

Specialization 52

Specialization Manufacturing Education Provider 52

FDA Law

MAY 8, 2023

See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

FEBRUARY 27, 2025

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. As such, we can offer our readers a special 10% discount. You can access the conference brochure and sign up for the event here. And it is exactly that! The discount code is: D10-999-FDA25.

Manufacturing 59

Manufacturing Specialization Provider IT 59

FDA Law

JANUARY 4, 2022

Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code.

Manufacturing 75

Manufacturing Specialization IT 75

GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

Healthcare 128

Healthcare IT Education Community 128