Tag Archives: ISPE

Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance

FDA official, Connie Jung PhD, Senior Advisor for Policy, spoke at the International Society of Pharmaceutical Engineering (ISPE) Serialization Workshops event yesterday to provide background on the Drug Supply Chain Security Act (DSCSA).  I used the opportunity to ask her a number of questions regarding some of the things I based my prediction in Monday’s essay that the FDA will announce a delay in the DSCSA in the next three weeks (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  The timing was perfect, and when I registered for the event, I didn’t even know the FDA was on the agenda.

Here’s the backstory. Continue reading Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance