GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
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
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Key Points: Illumina DNA sequencing machines are vulnerable to exploitation. Both the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have published advisories urging all...more
Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective...more
Whenever fact sheets or other guidance is issued by either the Office of the National Coordinator for Health Information Technology (ONC) or the Office for Civil Rights (OCR), it helps gain insight into the thinking of the...more
Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more
Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more
New Technology = New Threats - With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating. The...more
Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human...more
Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more
Is the Office of the National Coordinator for Health Information Technology (ONC) overstepping its statutory authority in pursuing enhanced regulatory activity? A June 3, 2014 letter from the House Committee on Energy and...more