Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
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
On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more
On August 6, the US Food and Drug Administration (FDA) issued an update regarding the use of per- and polyfluoroalkyl substances (PFAS), specifically fluoropolymers such as polytetrafluoroethylene (PTFE), in medical devices....more
Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The U.S. Food and Drug Administration (FDA) announced Tuesday a “Commissioner’s National Priority Voucher” (CNPV) program, which will provide a “limited number” of vouchers to sponsors of drug products that are “aligned with...more
Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more
On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more
California amends Prop 65 short-form warnings. California’s Office of Environmental Health Hazard Assessment has announced long-expected new amendments to its Prop 65 short-form warning requirements. ...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
On May 10, the U.S. Food and Drug Administration (“FDA”) released a new guidance document Guidance for Industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution,...more
In early 2023, the Biden administration announced and set into motion its plans to wind down a number of pandemic-related programs and allow the COVID-19 public health emergency (PHE) declaration, which has been in effect...more
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human...more
On January 31, 2022, FDA released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months. The guidance topics include several focused on plant-based...more
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
As we enter our seventeenth month of the COVID-19 pandemic, fears that the pandemic is once again getting out of control continue to rise. With COVID-19 cases increasing across the country, due in part to the contagiousness...more
On Wednesday, August 19, 2020, the U.S. District Court for the District of Columbia issued an order enjoining FDA from enforcing the premarket review requirement contained in the agency’s “Deeming Rule” against “premium...more
On May 12, the California Department of Consumer Affairs (DCA) issued an Order Waiving Restrictions on Pharmacists Ordering and Collecting Specimens for COVID-19 Tests, under the authority of California Governor Newsom’s...more
Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
On Saturday, 29 February 2020, the U.S. Food and Drug Administration (FDA) issued an “immediately in effect guidance” to swiftly expand testing for the novel coronavirus (2019-nCoV, formally named SARS-CoV-2), the causative...more
The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
LEGISLATION, REGULATIONS & STANDARDS - House Passes Cannabis Banking Bill - The U.S. House of Representatives has passed the SAFE Banking Act, which allows financial-service firms to work with “cannabis-related...more