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
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
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
The Food and Drug Administration (FDA) is not likely to continue to review and approve human drugs or medical devices if the federal government shuts down in March....more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a...more
As of Friday September 29, 2023, the United States Congress has yet to reach a spending agreement, as a result companies with international trade operations should prepare for a potential Federal government shutdown. The...more
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event of a shutdown, 19% of FDA employees would be...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include... ...more
While Congress has a two-week recess in April, there are many priority items on the agenda this month. Less than two weeks after signing the Fiscal Year (FY) 2022 spending package, President Biden released his budget for FY...more
In Washington: POLITICO reporter Burgess Everett tweeted that Senate Majority Leader Mitch McConnell (R-KY) says “negotiators should drop both state and local aid and liability shield provisions in order to reach consensus...more
Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: shutdown risk increases as talks stall; Gottlieb’s Hill testimony postponed; more bills...more
The federal government shutdown ended Friday, Jan. 25, 2019, with the enactment of a Continuing Resolution to fund government agencies at approximately FY19 levels through Feb. 15. That means federal employees are headed back...more
Note - On January 25, President Trump announced that the White House and congressional leaders in the House and Senate have reached an agreement to fund the government on a short-term continuing resolution (CR) through Feb....more
Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more
LEGISLATION, REGULATIONS & STANDARDS - Some FDA Inspectors Called to Work During Shutdown - In a series of tweets, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that about 200 food...more
Highlights this week: Gottlieb warns FDA’s funds running low as shutdown continues; House Dems launch sweeping probe on drug prices, Senate approves Medicaid measures, and more....more
LEGISLATION, REGULATIONS & STANDARDS - USDA Releases GMO Labeling Standard - The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service has released the final National Bioengineered Food Disclosure...more
As the government shutdown continues, administrative agencies have been updating the public on their operating status. The FDA has released a statement on its website explaining that its operations will “continue to the...more
During Shutdown, Commissioner Gottlieb Tries to Reassure Consumers – As the partial shutdown continues, Commissioner Scott Gottlieb tries to reassure the industry and consumers that the FDA will continue to execute its...more
Highlights this week: Nearly 7,000 FDA employees are furloughed amid the ongoing government shutdown; lawmakers introduce a slew of anti-pharma bills; 18 new Democrats land plum spots on key healthcare committees; and more....more
As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the...more
On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day. If the shutdown continues through the weekend, it will be the longest federal government shutdown in U.S....more
The new 116th Congress convened on Thursday, January 3, 2019 as the partial government shutdown, carrying over from the prior Congress, continued into the new year and has now outlasted previous shutdowns. Although the...more
On December 22, 2018, funding expired for certain agencies within the federal government, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS),...more
While many today returned to work after the Holiday season, things remained quieter than usual here in the nation’s capital – with many federal workers furloughed until further notice as the federal government continues to be...more