Newsletters

08.08.22

FDA Preemption: Implications of Dobbs Decision for Uniform Access to FDA-Approved Drugs in the U.S.

On June 24, in Dobbs v. Jackson Women’s Health Organization, the Supreme Court held that the “Constitution does not confer a right to abortion. Roe and Casey must be overruled, and the authority to regulate abortion must be returned to the people and their elected representatives.”


07.26.22

Negotiations on Reauthorizing FDA’s User Fee Programs Hit Snag

After weeks of bipartisan, bicameral negotiations on a legislative package to reauthorize FDA’s user fee programs, Senate Health, Education, Labor & Pensions (HELP) Committee Ranking Member Richard Burr (R-NC) withdrew from further conversations, citing disagreements with policies added ...


05.18.22

A Focal Point for FDA’s Rare Diseases Efforts: CDER’s New ARC Program

Last week, the Center for Drug Evaluation and Research at the Food and Drug Administration launched a new program to coordinate and centralize CDER’s rare disease activities.


04.21.22

New FDA Draft Guidance Encourages Industry Focus on Improving Clinical Trial Diversity

Last week, in the midst of the Biden Administration’s coordinated release of more than 90 “Equity Action Plans” by various federal agencies, the FDA issued a new draft guidance on enhancing clinical trial diversity.


04.14.22

CMS Aduhelm Decision: Precedent for Future Coverage or a One-Off?

On April 7, the Centers for Medicare & Medicaid Services released its highly anticipated final National Coverage Determination (NCD) for Aduhelm and other similar therapies in the pipeline for Alzheimer’s disease.