On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the FDA’s regulations to make explicit that in vitro diagnostic products (IVDs), including those manufactured by laboratories, are devices under the Federal Food, Drug, and Cosmetic…
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines (including those for rare diseases and children). On April 10, 2024, the European Parliament adopted its position on the European Commission’s legislative…
Goodwin’s Rare Disease Initiative hosted its Annual Rare Disease Symposium in Boston on March 13, 2024. Participants were invited to join for an afternoon of engaging and inspirational conversations led by Julie Tibbets, Matt Wetzel, and Danielle Lauzon, in addition to networking with peers in the rare disease community. The…
On April 1, 2024 the Federal Circuit released its opinion in Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., affirming the district court’s finding that certain claims were not indefinite and remanding to the district court to reevaluate its obviousness decision. The Federal Circuit’s analysis provides important considerations for life…
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…
