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
2023 was a momentous year for psychedelics, and it’s not just because we at Budding Trends started writing about them. There were wins for the psychedelic industry at the local, state, and federal levels, as well as in the...more
This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more
Votes in the 2022 Midterm Elections are still being tallied. It will likely take several more days, if not weeks, to be able to confirm who will hold the majority in the House and Senate.Please note that House, Senate, and...more
Outlook for This Week in the Nation’s Capital - Congress. Congress is in recess this week. Shortly after returning from the midterm election break, both parties will hold votes on their leadership. House Speaker Nancy Pelosi...more
Outlook for This Week in the Nation’s Capital - Congress. Congress is in recess to campaign for the upcoming midterms. Senate Majority Whip Dick Durbin (D-IL) on Wednesday said the Senate will focus on judicial nominations...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
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
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
BALLOT INITIATIVES - We’ll start in Arizona, where officials began verifying signatures this week. Polls show legalization is much more popular now than it was in 2016, when a legalization initiative was defeated. Not...more
On March 31, 2020, the United States Food and Drug Administration (FDA) issued guidance surrounding notification procedures if a manufacturer suffers a permanent discontinuance or interruption in manufacturing under the...more
Outlook for This Week in the Nation’s Capital - Recess. Both the House and Senate are in recess this week....more
Federal contractors already subject to a myriad of reporting requirements should be prepared for yet another. Effective December 23, 2019, a new Federal Acquisition Regulation (“FAR”) provision entitled “Reporting of...more
Outlook for This Week in the Nation’s Capital - Appropriations. All signs are currently positive that the appropriations process will wrap up in time to meet the December 20 deadline....more
Outlook for This Week in the Nation’s Capital - Recess. Congress is in recess until December 2 for the Thanksgiving holiday. Clark Hill wishes our readers a Happy Thanksgiving....more
Outlook for This Week in the Nation’s Capital - Appropriations. The Senate will continue its work on the appropriations process and attempt to pass its first series of FY20 bills, which include a package containing the...more
Outlook for This Week in the Nation's Capital - Minibus Appropriations Strategy. The House and Senate are planning to move appropriations bills in small packages of two or three bills in order to avoid a significantly delayed...more
Yesterday, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products...more
The exuberance of a November election victory for Republicans has given way to the difficult reality of passing legislation in a closely divided Senate. While the GOP has made significant gains in the area of regulatory...more
With the last-minute passage of a Continuing Resolution (CR) to stave off a government shutdown, the 114th Congress has come to an end. When Congress returns in January, it will be faced with a number of immediate challenges,...more
FDA Reform Tops Spring Work Period Agenda - The next work period basically runs from April 4 to May 27, with a both chambers adjourning for a week long recess the week of May 2nd. Following this work period, there will...more