13 Questions: FDA Product Identifier Guidance and Enforcement Discretion
How to plan for FDA enforcement discretion and product identifier guidance
A 45-minute on-demand webinar, recorded September 12, 2017
The DSCSA serialization requirement for manufacturers takes effect this November—and contrary to what you might think, the recent announcement of enforcement discretion doesn’t change that. What are the FDA's intentions with the guidance policy, what does it mean for your organization, and why are other pharmas continuing their serialization plans without delay?
This webinar will discuss:
- What we've seen so far.
- FDA intentions and what it means for manufacturers.
- Repackaging and grandfathering expectations.
- How to identify key milestones and build an effective timeline.
- How much risk you can expect in pausing your program.
- What your peers are already doing.
Brian Daleiden, VP Industry Marketing