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.

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Manufacturing Specialization IT 98

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 ).

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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.” See 42 U.S.C.

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Consulting Healthcare Professional Specialization Government 105

FDA Law

MARCH 6, 2024

HP&M is proud to have our professionals participating in these important events. Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. We can offer our readers a special discount for the event.

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Management Manufacturing Specialization Government 59

FDA Law

MARCH 9, 2025

The conference is the premier event on cosmetics and personal care products, where industry leaders will provide essential updates on compliance with Modernization of Cosmetics Regulation Act of 2022 (MoCRA), state legislative reforms, and new FTC advertising guidelines. As such, we can offer our readers a special 10% discount.

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Manufacturing Specialization Provider Management 59

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.

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Manufacturing Specialization Provider Clinic 59

FDA Law

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.

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Manufacturing Provider Medical IT 98