The presentation by Ian Deveau, PhD, from the US Food and Drug Administration (US FDA) Office of Compounding Quality and Compliance at the 2024 ISPE Annual Meeting & Expo on 15 October 2024 provided an in-depth look at the US FDA’s perspective on drug compounding, its regulatory framework, and the significant events that have shaped current practices. Here is a summary of the key points...
This blog summarizes a presentation by Rick Friedman, Deputy Director of the US FDA Office of Manufacturing Quality, on 17 April 2024 at the 2024 ISPE Europe Annual Conference in Lisbon, Portugal. The...
Carla J. Lundi, US Food and Drug Administration (FDA) Senior Consumer Safety Officer, Division of Quality Intelligence II, FDA, presented the regulatory keynote at the 2024 ISPE Facilities of the Future...
On Wednesday, 18 October 2023, Dr. Celia Lourenco, Associate Assistant Deputy Minister of Health Canada's Health Products and Food branch, presented a keynote address titled “Advanced Manufacturing and Other Trends Supporting Access to Medicines for Patients” at the
What is Commenting?
As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. ISPE submits official comments when we are able to provide that input.
ISPE’s commenting process is overseen by ISPE’s Regulatory Quality Harmonization Committee (RQHC)...
