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
Medical Device Legal News with Sam Bernstein: Episode 8
On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
Big Boosts to Cybersecurity and Tech Funding in $1.7T Omnibus Bill Signed by Biden - “The bipartisan fiscal 2023 omnibus spending agreement includes $2.9 billion for the Cybersecurity and Infrastructure Security Agency, a...more
The dust from the 2022 Midterm Elections has settled and the 118th Congress has begun. Republicans were successfully able to flip control of the House and now have a 222-212 majority with one vacancy to be filled. Democratic...more
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer Software Assurance for...more
On Tuesday, President Biden signed the Inflation Reduction Act of 2022 after it passed two party-line votes in the House (Final Vote: 220-207) and the Senate (Final Vote: 51-50) where Vice President Kamala Harris cast the...more
With just a few short weeks left until August recess, there is no shortage of items on the congressional to-do list. The latest round of Supreme Court decisions has inspired new action within Congress to pass legislation...more
Outlook for This Week in the Nation’s Capital - Congress. The House is in a committee work period this week, and the Senate is in recess....more
Well into the third year of the global pandemic, with record inflation and the uncertain outcomes of geopolitical issues roiling global markets, the cannabis industry has nevertheless continued upon a similar path as recent...more
Below is this week’s congressional update by BakerHostetler’s Federal Policy team. We’ll continue to post in weeks when both chambers of Congress are in session....more
Today, Monday, March 28, President Joe Biden unveiled his Fiscal Year (FY) 2023 budget request, the second of his presidency. The $5.7 trillion proposal calls for $1.7 trillion in discretionary spending and $3.7 trillion in...more
Despite February being a short month, various proposals are still on the table. As Congress returns from recess this week, it faces a daunting to-do list. Government funding runs out by mid-February, Democrats are looking for...more
As anticipated, 2021 was an eventful year for the regulation of per- and polyfluoroalkyl substances (“PFAS”) at the federal level. BCLP has highlighted the key developments in this document, but this is not intended to be a...more
On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a...more
A recent study of one of the two mRNA-based vaccines revealed positive news on how long the vaccine will effectively prevent against COVID-19 infection. The pandemic has also revealed societal weaknesses that, if addressed,...more
On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more
In Washington - The House will meet for a pro forma session on Monday and the full House is out of session next week. The Senate will reconvene on Monday and resume consideration of John Badalamenti to be United States...more
As restaurants and other retail food establishments begin to reopen around the country, trade associations and the US Food and Drug Administration (FDA) have both issued guidance for retail food establishments that provide...more
The U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) recently updated their respective COVID-19 questions and answers guidance. FDA updated its food safety questions and answers guidance on...more
...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more
The U.S. Food and Drug Administration (FDA) announced a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited – may introduce risks for certain Bluetooth enabled medical devices. ...more
Outlook for This Week in the Nation's Capital - Minibus on Senate Floor. The Senate is expected to take up a four-bill spending package next week. ...more
On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more
Tax Vote This Week: After Senators Corker and Rubio announced their support of the tax bill on Friday afternoon, both Chambers announced their plans to move forward with voting on the compromise tax package this week. The...more
Continuing Resolution for an Additional Month or Two Becoming More Likely: Key appropriators say lawmakers have discussed a continuing resolution that runs until early February despite previous reports that Congress expected...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