I hope you were able to attend last Friday’s FDA DSCSA Public Meeting at FDA’s White Oak, Maryland campus (see “FDA To Hold DSCSA Public Meeting”). If you missed it, make sure you listen in on the recording that the FDA will provide on the event webpage. You can also submit written comments through that page as well. The event was called “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (DSCSA)” and it consisted of very brief introductory comments by the FDA followed by presentations made by attendees who applied for a speaking slot. Presentations covering progress toward the November 27, 2017 DSCSA serialization requirements were made by: Continue reading FDA Forfeits Opportunity To Guide Industry
Last week, Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity, & Recalls, U.S. Food and Drug Administration, spoke about the Drug Supply Chain Security Act (DSCSA) at the GS1 US Connect event in Washington DC. This was our latest opportunity to get a glimpse of what the FDA is thinking and what they are doing. Dr. Jung spoke for about 50 minutes and then answered questions from the audience. Continue reading FDA Speaks At GS1 Connect
Connie T. Jung, RPh, PhD, Acting Associate Director of Policy and Communications, Office of Drug Security, Integrity and Recalls, in the Office of Compliance within the U.S. FDA Center for Drug Evaluation and Research (CDER) delivered an overview of the new Drug Supply Chain Security Act (DSCSA) during a webinar last Monday. The title of the webinar was “FDA Perspectives on Implementation of the Drug Supply Chain Security Act”. The webinar is one of a series that the Healthcare Distribution Management Association (HDMA) plans to offer on related topics through the remainder of the year. If you missed it, don’t worry, they will post the recording and the slides on the HDMA event web page.
I have to give credit to Dr. Jung and the FDA in general for being willing to make presentations like this at this time. The material they cover is a good overview of the new law at a high level. The tough part for the speaker comes at the end when the floor is opened up for Q&A. There were a number of very good questions asked by participants on this one, but most were answered with simple reference to future guidance. Here is Dr. Jung’s answer to Continue reading DSCSA: Many Questions, Few Answers