Brooke Bumpers

May 22, 2024 | jdsupra.com | Brooke Bumpers |Lindsey Johnson |Beth Roberts

Many Americans have been following the implementation and enforcement of new state laws and new interpretations of existing laws governing abortion since the Supreme Court, in Dobbs v. Jackson Women’s Health Organization, overturned its longstanding precedents on abortion on June 24, 2022. Recently, public attention has focused on state court opinions that interpret and apply these abortion laws.

May 21, 2024 | lexology.com | Lindsey Johnson |Brooke Bumpers |Beth Roberts

New, or newly interpreted, state laws and court decisions governing abortion may directly affect access to medical care and treatment for patients who are, or who want to become, pregnant. They also have potential implications for researchers and manufacturers who use embryonic stem cells and cell lines to develop new therapies.

May 7, 2024 | jdsupra.com | Erkang Ai |Brooke Bumpers |Suzanne Friedman

FDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR § 809.3 to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.” We previously analyzed the October 2023 proposed rule (Notice of Proposed Rulemaking (NPRM)) online here, providing background in that article on FDA’s decades-long history of exercising enforcement...

May 6, 2024 | lexology.com | Jodi Scott |Lowell Zeta |Blake Wilson |Randy Prebula |Brooke Bumpers |Suzanne Friedman | +2 more

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the most notable changes between the proposed rule and Final Rule, including the grandfathering provision and inclusion of more carve-outs for categories of tests that will continue to receive enforcement discretion.