STAT

Medicare’s new transitional coverage of emerging technologies program doesn’t go far enough

Neumann is director of the Center for the Evaluation of Value and Risk (CEVR) at Tufts Medical Center. Crummer is a research assistant at CEVR. Kaltenboeck is a principal and head of prescription drug ...
RAPS

FDA official offers insights on Emerging Technology Program

The US Food and Drug Administration (FDA) accepts a wide variety of applications into its Emerging Technologies Program (ETP), and is not just focused on continuous manufacturing, said Joel Welch, ...
RAPS

FDA Finalizes Guidance on Emerging Manufacturing Tech Program

FDA Finalizes Guidance on Emerging Manufacturing Tech Program The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's ...
JD Supra

DOJ Updates Corporate Compliance Program Guidance With a Focus on AI and Emerging Technologies

The Situation: In September 2024, the U.S. Department of Justice ("DOJ" or "Department") announced updates to its Evaluation of Corporate Compliance Programs guidance covering three primary areas: (1) ...
Nasdaq

Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program

N-Sorb leverages Aptar CSP Technologies’ proven 3-Phase Activ-Polymer™ platform technology to address the pressing issue of N-nitrosamine impurities in pharmaceuticals. These impurities, classified as ...