FDA's Monica Caphart to Speak at PDA Clinical Trial Supplies Conference
Caphart will join other regulators to examine the various regulations that impact the preparation and distribution of Clinical Trial Materials (CTMs). Don’t miss this opportunity to learn directly from the experts! Reserve your seat today!
Parametric Release Draft Published by US FDA
The US FDA has published a draft guidance for industry entitled, Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. Comments are being solicited and must be submitted by October 6, 2008.
U.S. FDA Seeks Volunteers for QbD Biotech Pilot Program
The FDA is looking for companies to participate in its quality-by-design (QbD) pilot program for biotechnology submissions, which is intended to help the Agency develop a guidance on the topic.
Call for Papers: Emerging Technologies