FDA publishes update to the guidance, Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
A special thanks to our sponsors for The Gala Dinner Soiree at The Skyline at Waterplace in the in the charming "Renaissance City of Providence".
IPEC-Americas submit comments on FDA's Quality Metrics
Omni Providence Preferred Hotel Rate Ends March 24! The focus of the April 24-26, 2017 conference and expo is on Regulatory, Supply Chain, and Excipients for Biologics
Priscilla Zawislak, IPEC-Americas Chair, presents an overview of the the organizations 2016 accomplishments.
IPEC-Americas has developed a position paper to help industry review and reflect on the real purpose and/or utility of excipient DMFs.