Regulatory Affairs Professionals Society

FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program

Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
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 ...
Business Wire

Prolific Machines Selected to Join FDA's Emerging Technology Program, Advancing the Company’s Novel Biomanufacturing Platform

EMERYVILLE, Calif.--(BUSINESS WIRE)--Prolific Machines, a biotechnology company revolutionizing biologics manufacturing, announced today that it has been accepted into the U.S. Food and Drug ...
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 ...