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
Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the Biden administration's proposed insurance rule regarding mental health and substance use...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more
Last week, the Centers for Medicare & Medicaid Services (CMS) issued a final procedural notice for the new Transitional Coverage for Emerging Technologies (TCET) pathway for certain US Food & Drug Administration (FDA)...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Obesity is a complex, multifactorial disease that has serious health consequences, affects millions of Americans and drives hundreds of billions of dollars in annual health care spending. Scientific understanding of the...more
There is a critical need to increase access to evidence-based care for justice-involved pregnant people with a substance use disorder (SUD)—and connect them to continued coverage and care upon release—according to national...more
Editor’s Note: In a new white paper, summarized below, Manatt Health discusses emerging reimbursement models for cell and gene therapies. The paper provides an overview of current Medicaid, Medicare and commercial coverage,...more
Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...more
The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more
Prenatal vaccines—those administered during a pregnancy—provide crucial protections to pregnant women and/or newborns against communicable diseases such as whooping cough and influenza. Additional prenatal vaccines are in...more
Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more
When reformers look for ways to slash the ever-higher costs of American medical care, one line item should leap from television screens, print pages, and radio broadcasts: How does the nation benefit from medical enterprises...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “Public Policy Weekly* Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please...more
The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more
On December 13, 2016 President Obama signed into law the 21st Century Cures Act. The law had been approved with bipartisan support in the House by a vote of 392 to 26 and in the Senate by a vote of 94 to 5. The law addresses...more
The election of Donald J. Trump as the 45th President of the United States, along with the Republican control of the majority of both the House of Representatives and the Senate, will likely set in motion a major overhaul of...more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more
Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more
On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more
Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more
This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more
The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more