On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products.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 tools.
The guidance
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 Trade Commission (FTC), continued momentum
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 attend in-person or via
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 The final guidance supersedes the agency’s revised draft guidance of the same title issued in October 2023 (see our analysis of the draft guidance
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 about the Q1 2025 updates
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 grant
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 research and improve care for
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 on the growing role
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 & Compliance team has provided
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade Commission (FTC) is continuing to closely examine life sciences transactions for both horizontal and vertical concerns. The agency also continues
