Medtech mergers and acquisitions (M&A) and venture capital (VC) showed signs of life in 2024, contributing to an overall optimistic outlook for the sector this year despite lingering headwinds. Strategic investments are expected to continue as medtech companies innovate, particularly in areas such as AI-driven diagnostics, wearables and remote monitoring... Read More The post Medtech M&A and VC Signal Positive Momentum Entering 2025 appeared first on Life Sciences Perspectives ..read more

On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. The document clarifies how sponsors, manufacturers, and other industry developers should approach artificial intelligence (AI) to support safe, effective development and marketing of AI-based... Read More The post FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products appeared first on Life Sciences Perspectives ..read more

Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming months and years is emerging. Anticipated changes span multiple regulatory fronts: a revamped approach to antitrust review at the Federal... Read More The post How the Trump Administration Could Reshape Regulation in the Life Sciences Sector appeared first on Life Sciences Perspectives ..read more

Goodwin’s Life Sciences team is excited to host its Annual Rare Disease Symposium in Boston on February 5, 2025. Participants are invited to join for an afternoon of engaging fireside chats, inspirational presentations, and networking with peers in the rare disease community.   Please see the agenda below and register to... Read More The post Goodwin Invites You to Join Us For Our Rare Disease Symposium 2025 appeared first on Life Sciences Perspectives ..read more

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” The final guidance supersedes the agency’s revised draft guidance of the same title issued in October 2023 (see our... Read More The post How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information appeared first on Life Sciences Perspectives ..read more

To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory & Compliance team has provided an overview of key developments. We update and publish a quarterly tracker detailing these developments. You can read... Read More The post A Look Ahead in Life Sciences: What We Are Tracking in the First Quarter of 2025 and Beyond appeared first on Life Sciences Perspectives ..read more

In October, NORD will also hold its annual Breakthrough Summit in Washington, DC on October 20-22, 2024.  This event draws over 1,000 attendees including patients/caregivers, patient advocacy organizations, and healthcare, biotech, and medical technology companies.  Registration is available here. This year, Matt Wetzel will take part in a panel discussion... Read More The post NORD Annual Breakthrough Summit appeared first on Life Sciences Perspectives ..read more

On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR). The bill (H.R.9938) mirrors a US Senate version that was introduced in May 2024 (S.4426) that would authorize the US Food  and Drug Administration (FDA) to... Read More The post New Momentum for a Time-Limited Conditional Approval Pathway for Rare Disease Drugs appeared first on Life Sciences Perspectives ..read more

Support Goodwin’s DC Life Sciences Team as they raise money for the National Organization for Rare Disorders (NORD) as part of its “Running for Rare” team at the annual 10K race held during the upcoming DC Marine Corps Marathon on October 27th. Assist NORD’s mission to drive public policy, accelerate... Read More The post Running for Rare for NORD appeared first on Life Sciences Perspectives ..read more

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and regulations across pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, our Life Sciences Regulatory... Read More The post A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond appeared first on Life Sciences Perspectives ..read more