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
The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is publishing a proposed rule (Proposal or NPRM) that will require broad segments of industry to meet onerous and quick...more
Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...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
In Washington: The Centers for Disease Control and Prevention (CDC) has loosened its COVID-19 guidelines for summer camps, saying that vaccinated staffers and adolescents do not need to wear masks. The changes represent an...more
Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more
On March 18, 2020, the United States Food and Drug Administration (FDA) announced the suspension of all domestic routine surveillance facility inspections until further notice. FDA took this measure to protect the health and...more
The U.S. Food and Drug Administration (FDA) said Friday it plans to resume on-site inspections of FDA-regulated facilities and other associated activities the week of July 20, 2020. The agency had temporarily halted most...more
Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light...more
The U.S. Food and Drug Administration (FDA) recently released guidance regarding compliance with the shell Egg Safety Rule during the COVID-19 pandemic to facilitate the distribution of eggs to retail. The agency also updated...more
This memorandum summarizes recent actions the U.S. Food and Drug Administration (FDA) has taken in response to the COVID-19 outbreak. First, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas issued a food...more
This post summarizes recent actions the federal government has taken in response to the COVID-19 outbreak. First, the Department of Homeland Security’s (DHS’s) Cybersecurity & Infrastructure Security Agency (CISA) has updated...more
Production of animal food, like human food, is an essential function Americans depend on daily, reinforced by the Department of Homeland Security in its Guidance on the Essential Critical Infrastructure Workforce: Ensuring...more
As the novel coronavirus (COVID-19) crisis continues to present new questions and challenges, the U.S. Food and Drug Administration (FDA) continues to update its website to provide additional information and guidance to the...more
The current outbreak of COVID-19 (the coronoavirus) will be a test of the global supply chain’s strength in the face of unintended interruptions, and can be a lesson on building-in supply-chain contingency plans. As a result...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. It was a busy week for the states, as Virginia moved towards decriminalization. The state House and Senate passed...more
Autonomous cars, sports betting, and CBD products have burst onto the scene, setting the stage for major developments in how companies do business and how regulators monitor new innovations....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
UNITED STATES - Regulatory—Policy, Best Practices, and Standards - NIST Produces Roadmap for Improving Critical Infrastructure Cybersecurity Version 1.1 - On April 25, the National Institute of Standards and Technology...more
LEGISLATION, REGULATIONS & STANDARDS - “Shame on you, Washington Post”: FSIS Criticizes Reporting on Pork Inspections - The U.S. Food and Drug Administration’s Food Safety and Inspection Service (FSIS) has issued a...more
The 2018 Midterm Election played out as most poll forecasters speculated. Although several races have yet to be decided, Republicans have retained control of the Senate, but lost at least 29 seats, allowing the Democrats to...more
Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing risks coming from nation states, nonstate actors and other attackers. The...more
Holland & Knight invites you to read our Winter 2017 Israel Practice newsletter, in which our authors discuss pertinent American-Israeli topics. As Israel has been a crossroads and a prolific source of new ideas for more than...more
UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Comments on Improvements to IoT Device Security - On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the...more