AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
Teladoc has sued competitor Amwell over patent claims in the U.S. District Court for the District of Delaware. Teladoc is accusing Amwell of infringing on its patents related to telehealth carts, a digital scope and...more
Patent term extension (PTE) is available under the 1984 Drug Price Competition and Patent Restoration Act, also known as the Hatch-Waxman Act (The Act). The Act allows the extension of the term of a patent claiming a product...more
The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more
Many global markets have been impacted by COVID-19, including the medical product and food industries. Both sectors are particularly critical as medical products are relied upon to help abate the disease and as communities...more
Food/Dietary Supplements - FDA Issues Warning Letters to Companies Selling Cannabidiol-Containing Products – The FDA announced it issued warning letters to 15 companies “for illegally selling products containing cannabidiol...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
Food/Dietary Supplements - FDA Will Hold Public Meeting on Food Standards of Identity – The meeting will be held on Sept. 27, 2019, and is intended “to give interested parties an opportunity to discuss FDA’s effort to...more
Food/Dietary Supplements - FDA Remarks at National Industrial Hemp Council 2019 Hemp Business Summit – The Principal Associate Commissioner for Policy for the FDA stated, “We’ve seen rapidly growing interest in marketing...more
On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more
Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
Food/Dietary Supplements - FDA Commissioner Announces Ongoing Services During the Partial Government Shutdown – The FDA released a statement that certain programs would continue to run during the shutdown. ...more
Welcome to the third issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues. For this edition, we are reporting on several important and timely legal issues. As you...more
Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration...more
Massachusetts Federal Court Dismisses Putative Class Action Because Defendant’s Unconditional Checks for Named Plaintiff’s Maximum Damages, Even Though Uncashed, Mooted Suit - In Demmler v. ACH Food Companies, Civil No....more
AGG produces a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from our Washington, DC office. The June 2015 update is now available....more
The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). The...more
Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more