In the wake of recent mass layoffs at the U.S. Food and Drug Administration (“FDA”), the FDA is likely to have fewer resources to manage its regulatory responsibilities. One area that may be significantly impacted by such...more
The life sciences industry experienced a dynamic year in 2024. As the public markets gained traction, IPO activity and venture investment saw a resurgence, signaling renewed investor confidence and reflecting sustained...more
More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more
1/10/2025
/ Biotechnology ,
Business Strategies ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Investigational New Drug Application (IND) ,
Licensing Rules ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Pricing ,
Regulatory Reform ,
Regulatory Requirements ,
Variable Rates