FDA Law Blog
NOVEMBER 6, 2023
is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. life sciences industry. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C.
FDA Law Blog
MARCH 6, 2024
The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.
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Pharma in Brief
NOVEMBER 20, 2023
The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. Natural health product vs. regulated drug In Winning Combination Inc. In its August 16, 2023 decision in Le-Vel Brands, LLC v.
pharmaphorum
SEPTEMBER 29, 2022
The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.
FDA Law Blog
JANUARY 24, 2024
For nearly 20 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA law and regulation. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. Join our co-chairs Kurt R.
Pharma in Brief
JANUARY 7, 2024
Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to be seen. As we reported , the export regulations first issued as an interim order in November 2020, in response to the FDA publishing the US Importation Rule in October 2020. 01.014.13).
pharmaphorum
OCTOBER 27, 2022
Discussion Forums – If discussion forums are hosted or facilitated by a company, the company should be confident it can moderate the forum such that the content complies with relevant regulations, laws, and codes. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders? About the authors.
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