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 or the agency) has issued a final Guidance on the Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls (Guidance)....more
On March 24, 2020, the US Food and Drug Administration (“FDA”) issued Guidance[1] suspending the enforcement of certain veterinarian-client-patient relationship (“VCPR”) requirements to help veterinarians provide animal...more
The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive...more
We are approximately nine months into FDA’s animal feed and pet food facility inspections for compliance with the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food (PC) rule. With PC inspections...more
FSMA, Prop. 65 and Supply Chain Issues Among Subjects of Food Law Conferenc - In-house and outside counsel joined representatives from the U.S. Food and Drug Administration (FDA), Department of Agriculture (USDA) and...more
Food/Dietary Supplements - FDA Releases Report on Food-borne Illness – The FDA issued a report on the prevalence of food-borne illness risk factors in fast-food and full-service restaurants. ...more
The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA). Together with the release of this...more
The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier...more
Top News - FDA Announces Intention to Not Enforce Certain FSMA Final Rules Provisions - On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce...more
The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final and on April 5, 2017, the FDA published three waivers for certain qualifying businesses. The Sanitary...more
FDA Amends Waivers to Sanitary Transportation Rule - On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more
Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more
Earlier today, FDA finalized the first set of major rules implementing the Food Safety Modernization Act (FSMA) – regulations addressing current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive...more
On October 29, 2013 (the “Publication Date”), the Food and Drug Administration (“FDA”) published in the Federal Register its latest set of proposed regulations implementing the Food Safety Modernization Act (“FSMA”). The...more