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Food and Drug Administration (FDA) Innovation

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

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Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

Foley & Lardner LLP on

The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more

Sheppard Mullin Richter & Hampton LLP

Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more

Wilson Sonsini Goodrich & Rosati

[Event] 32nd Annual Medical Device & Digital Health Conference - June 5th - 6th, San Francisco, CA

Join medical device and digital health entrepreneurs, CEOs of venture-backed companies, and business development executives from large Medtech and digital health companies, as well as angels, venture capitalists, and...more

Goodwin

Goodwin’s 2025 Rare Disease Symposium: Momentum Builds for Addressing Critical Diagnosis and Treatment Gaps

Goodwin on

Goodwin’s 2025 Rare Disease Symposium, held on February 5 in Boston and virtually, gathered patient advocates and caregivers, providers, researchers, biotech and medtech leaders, investors, and policy experts to discuss the...more

Morgan Lewis - As Prescribed

FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Bergeson & Campbell, P.C.

NNCO Releases NNI Supplement to President Biden’s 2025 Budget

On December 19, 2024, the National Nanotechnology Coordination Office (NNCO) released The National Nanotechnology Initiative Supplement to the President’s 2025 Budget, which also serves as the annual report for the National...more

Foley & Lardner LLP

Yes, You Can Patent Food Products!

Foley & Lardner LLP on

Companies in the food and beverage industry might overlook significant advantages by not patenting their innovations. While there’s a common belief that “recipes” cannot be patented, unique formulations and other aspects of...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments...

Maynard Nexsen on

Heather and Matthew welcome Dr. Gil Price, who has had an impressive career in the life sciences industry as a recently retired executive and currently serves as a board member for numerous companies. As an experienced leader...more

Benesch

Dental/DSO Intelligence Monthly Report: June/July 2024

Benesch on

A study at the University of Illinois Chicago College of Dentistry developed a chatbot using information reviewed by faculty members to answer questions about clinical procedures. Cortino Sukotjo, DDS, PhD, a professor of...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - June 2024

Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

Troutman Pepper Locke

The FDA's Response to AI Medical Innovation — The Good Bot Podcast

Troutman Pepper Locke on

Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...more

Wilson Sonsini Goodrich & Rosati

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

Gardner Law

From Discretion to Regulation: FDA's New Path for LDTs

Gardner Law on

Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren welcome Dr. Ehsan Samei and Dr. Susan Halabi, leaders of the new Triangle CERSI, which stands for the Center of Excellence in Regulatory...more

Foley & Lardner LLP

Strengthening the Flow of the Biotech Sector’s M&A Pipeline

Foley & Lardner LLP on

Originally published in Genetic Engineering News on October 10, 2023. Reprinted with permission. The biotechnology sector has long been characterized by its constant innovation, rapid technological progress, and unyielding...more

Nelson Mullins Riley & Scarborough LLP

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] 2023 Medical Device Digital Health Conference - June 16th, San Francisco, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] MDC 2023 Reception & Dinner Women’s Networking Event & Program - June 15th, Menlo Park, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Holland & Knight LLP

Holland & Knight Health Dose: December 13, 2022

Holland & Knight LLP on

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

Knobbe Martens

FDA to Collaborate with Veterans group on Medical Device Innovation

Knobbe Martens on

On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures Innovation Institute. According to the FDA, the intent of the collaboration is to “help...more

Faegre Drinker Biddle & Reath LLP

Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more

Goodwin

Executive Order for Advancing Biotechnology and Biomanufacturing Innovation Signed by President Biden

Goodwin on

​​​​​​​On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order...more

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