DSCSA Mid Point

Hello All!

We are coming up to the midpoint of the FDAs stabilization period allowed for the industry to prepare for DSCSA compliance. Are you still moving forward? Testing your processes?

At the 2024 FDLI Annual Conference on Wednesday, May 15, 2024, Patrizia Cavazzoni, director of FDAs Center for Drug Evaluation and Research (CDER) made statements about the stabilization period. Cavazzoni stated at the meeting that facilities should not expect any more delays. She stated, “I really want to emphasize that this is not really a matter of kicking the can down the road.”

People are encouraged by FDA to sign up for a meeting on June 18, 2024. This meeting will focus on DSCSA readiness. It is considered a “midway check” for industry. It may be a good time also to exchange “lessons learned” and discuss problems with vendors seen by facilities.

Deep down I was hoping (well most people were hoping) they would “kick the can down the road” a little further. Looks like that will be a no go.

A little more detail about the meeting attended by Ms. Cavazzoni can be found here:

https://www.raps.org/news-and-articles/news-articles/2024/5/cavazzoni-no-more-%E2%80%98kicking-the-can-down-the-road-f?utm_campaign=Regulatory-Focus&utm_source=linkedin&utm_medium=social

Thanks All!

Jay G.