Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more
On August 2, the U.S. Court of Appeals for the Eighth Circuit decided a case addressing Nebraska’s authority to require tribal cigarette manufacturers that are not parties to the Master Settlement Agreement (MSA) to comply...more
The U.S. Food and Drug Administration (“FDA”) recently announced that grease-proofing substances containing per and poly-fluoroalkyl substances (“PFAS”) are no longer being sold by manufacturers for food contact use in the...more
Food and beverage companies may be surprised to learn that the U.S. Food and Drug Administration (“FDA”) is not the exclusive regulatory authority over the safety of foods and beverages. Indeed, other governmental authorities...more
In 2023, the U.S. Food and Drug Administration (FDA) took several steps to implement the Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law in December 2022. The law requires cosmetic manufacturers...more
The Food and Drug Administration (“FDA”) will begin enforcement of the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) on July 1, 2024. MoCRA represents the biggest regulatory overhaul for the cosmetics industry...more
The U.S. Food and Drug Administration (FDA) had a busy end of 2023 regarding cosmetics facility registration and product listing, which are now required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)....more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought significant changes for the US Food and Drug Administration’s (FDA’s) regulation of cosmetic products. Recent FDA action, including the issuance of final...more
Key Takeaways - What Happened: The Food and Drug Administration (FDA) released four updates regarding MoCRA in December....more
As the December 29, 2023 deadline for certain aspects of the Modernization of Cosmetics Regulation Act (“MoCRA”) approaches, FDA has finalized its guidance document governing the registration of cosmetic manufacturing...more
The U.S. Food and Drug Administration (FDA) has announced that it intends to delay enforcement of cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act...more
Key Takeaways - What Happened: FDA announced delayed enforcement for MoCRA facility registration and product listing information....more
The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) is part of the Food and Drug Omnibus Reform Act of 2022 (FDORA) that President Biden signed into law late last year. MoCRA greatly expands the FDA’s oversight...more
The U.S. Environmental Protection Agency (EPA) is not the only federal agency that regulates per- and polyfluoroalkyl substances (PFAS). And states aren't the only ones scrutinizing PFAS in food packaging products. PFAS,...more
Earlier this month, in a step toward implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA issued a draft guidance document titled “Registration and Listing of Cosmetic Product Facilities and...more
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. As we...more
Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more
On Aug. 14, the Ninth Circuit issued its decision in Nacarino v. Kashi Co., providing some much-needed clarity to the FDA’s protein labeling requirements. The decision dealt with two separate cases from the Northern District...more
On August 7, 2023, the U.S. Food and Drug Administration (FDA, the Agency) published draft guidance aimed at assisting cosmetics companies with achieving and maintaining compliance with new cosmetic product facility...more
The U.S. Food and Drug Administration (FDA) issued draft guidance for industry on the registration and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on August 7, 2023. The...more
Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) released Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, providing more information on the newly...more
On August 7, 2023, FDA issued a draft guidance document entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry (“The Draft Guidance”), providing FDA’s current thoughts on the...more
Facility Registration: What Is a Facility and Who Has to Register? Section 607 of MoCRA requires the registration of facilities that manufacture or process cosmetics for distribution in the United States. While this...more
The proposed rule, if finalized, would impose new manufacturing practice requirements on foreign and domestic manufacturers of finished and bulk tobacco products. On March 10, 2023, the Food and Drug Administration (FDA...more
In a prior update, we discussed the ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA) March 2020 rule on a graphic-warning requirement for cigarettes. Initially slated to take effect June 18, 2021, the...more