Nano and Other Emerging Chemical Technologies Blog

Nano and Other Emerging Chemical Technologies Blog

Regulatory & legal developments involving nano and other emerging chemical technologies

Tag Archives: CDER

FDA CDER Identifies Nanotechnology as Area of Interest for Site Visit Training Program for OPQ Staff

Posted in Federal, Legal/Regulatory Issues, United States
The Food and Drug Administration (FDA) published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program.  According to the notice, “[a] critical part of the commitment by CDER to make safe and effective high-quality drugs… Continue Reading

FDA Posts MAPP on Reporting Format for Nanotechnology-Related Information

Posted in Federal, Legal/Regulatory Issues, Research, United States
On June 3, 2010, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science (OPS) posted on its website a Manual of Policies and Procedures (MAPP) entitled “Reporting Format for Nanotechnology-Related Information in CMC Review.” The purpose of the MAPP is to provide chemistry, manufacturing, and controls (CMC) reviewers… Continue Reading

FDA Panel States FDA Wants More Information before Issuing Guidance

Posted in Federal, Legal/Regulatory Issues, Research, United States
During the February 18, 2009, Food and Drug Law Institute’s Second Annual Conference on Nanotechnology Law, Regulation, and Policy, Dr. Jonathan Sackner-Bernstein, Associate Center Director for Post-Market Operations at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), stated that FDA will not issue guidance until companies bring products to them… Continue Reading