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PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

FDA Law

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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ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law

HP&M is proud to have our professionals participating in these important events. Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. On March 20-21, Counsel John W.M.

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ACI’s 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care

FDA Law

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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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

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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ACI’s 43rd FDA Boot Camp – New York City Edition

FDA Law

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!

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Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. What do we do to very concretely provide heat shelters and cool shelters?