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
This Friday is the deadline to pass a budget or enter a government shutdown. The House released a continuing resolution (CR) over the weekend and is scheduled to be in session only until Wednesday. The House Rules Committee...more
Navigating the Trump administration executive order impacting pediatric gender dysphoria evidence, coverage, disclosures, regulation, legislation, and enforcement as well as grants to certain medical institutions, including...more
The Biomedical Advanced Research and Development Authority (BARDA) held its first in-person BARDA Industry Day (BID) since the beginning of the COVID-19 pandemic in Washington, D.C., on November 13-14, 2023. BID is an annual...more
I'm not saying that anyone from the Biden administration was reading my blog post last week on drug shortages, and maybe it's just a coincidence that the White House announced new efforts to strengthen supply chains less than...more
Earlier this week, the Biden Administration announced a monumental plan to address impacts stemming from per- and polyfluoroalkyl compounds (PFAS). While the announcement details the ongoing and future efforts of eight...more
For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more
Below, please find a summary of recent federal government activity in response to the COVID-19 pandemic. Congress - On Tuesday, after returning from the August recess, Senate Republicans unveiled a “targeted” COVID...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
Below, please find a summary of the federal government’s activities in response to COVID-19 since Friday’s update. Our next update will be published Wednesday, July 22....more
Below, please find a summary of the federal government’s activities in response to COVID-19 since our last update. Please note that in light of the Congressional recess, we will only publish updates on Mondays, Wednesdays,...more
Below, please find a summary of today’s federal government activities in response to COVID-19. Congress - During today’s Senate Small Business Committee hearing on CARES Act small business lending programs, Ranking...more
Outlook for This Week in the Nation’s Capital - Impeachment Trial Continues. House trial managers completed their arguments for impeaching President Trump, while the President’s lawyers are continuing their defense. ...more
UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Submits Comment on the Preliminary Draft for the NIST Privacy Framework - On October 24, 2019, the Federal Trade Commission ("FTC") announced that...more
Outlook for This Week in the Nation's Capital - Continuing Resolution. The House is scheduled to take up a “clean” continuing resolution to continue funding the government after the current fiscal year expires on September...more
Outlook for This Week in the Nation's Capital - Recess Week. The House and Senate are both in recess this week for the 4th of July holiday. Clark Hill wishes you a safe and enjoyable Independence Day....more
President Donald Trump on February 12, 2018, submitted his budget request to Congress for Fiscal Year (FY) 2019. The President's full budget calls for approximately $4.4 trillion in total spending. Much of the budget seeks...more
Hurricane Harvey Could be the Most Expensive Natural Disaster in US History: Republican House members from Texas and Louisiana are pressing congressional leaders and top Trump administration officials for immediate federal...more
CBO Confirms Size of Breach of Defense Cap for FY18 Bills: The House FY18 Omnibus Appropriations Bill scheduled to be taken up in September would bust the Defense cap by $72 billion. This would cause the Office of Management...more
I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more