Editor’s Note: To help you easily access all of Manatt Health’s thought leadership on Dobbs and other reproductive health issues, we have created a new Reproductive Health “hot topics” page on our website. Now one click takes...more
Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy -
Although increasing representation of underserved populations in clinical trials has...more
The Big Picture -
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 [v. Wade] and Casey [v. Planned Parenthood] must be...more
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...more
Last week, the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) launched a new program to coordinate and centralize CDER’s rare disease activities. The mission of the Accelerating Rare...more
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coordinated release of more than 90 “Equity Action Plans” by various federal agencies, the FDA issued a new draft guidance on enhancing clinical trial diversity. In a...more
4/21/2022
/ Biden Administration ,
Clinical Trials ,
Disparate Impact ,
Diversity and Inclusion Standards (D&I) ,
Draft Guidance ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Research and Development
On April 7, the Centers for Medicare & Medicaid Services (CMS) released its highly anticipated final National Coverage Determination (NCD) for Aduhelm and other similar therapies in the pipeline for Alzheimer’s disease. The...more
We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and developments. A new commissioner has been confirmed (Robert Califf, M.D., who previously...more
4/11/2022
/ Biden Administration ,
Biologics ,
Biosimilars ,
Coronavirus/COVID-19 ,
FDA Commissioner ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
User Fees ,
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