The two days after the next FDA DSCSA Public Meeting, IQPC will hold their Pharmaceutical Traceability Forum | Interactive event in Washington DC. The FDA meeting will be on December 5 and 6, and the IQPC event will be on December 7 and 8. Perfect for attending two vitally important meetings, and only having to travel once. The Pharmaceutical Traceability Forum | Interactive event includes a slate of excellent speakers who will provide you with their immediate impressions of the FDA meeting that will have just occurred, and the one that was held back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”). Continue reading Sponsored: FDA DSCSA Public Meeting Q&A
Tag Archives: FDA Public Meeting
Sponsored: Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events
There is a rare alignment of events that will happen in the first week of December that is so special that you need to put it on your calendar. There are two important pharma serialization events that will occur in the Washington DC area and anyone with a serious interest in that subject should attend both. These events line up perfectly to allow you to travel once, and spend four days that will solidify your understanding of the issues and opportunities embedded within the Drug Supply Chain Security Act (DSCSA) in particular, and pharma serialization in general. Continue reading Sponsored: Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events
FDA DSCSA Public Meeting #1 Exposes Gulf In Goals
The FDA held the first of three scheduled DSCSA public meetings last week. This one focused on:
- The vision for 2023; and,
- The enhanced drug distribution security (EDDS) needs related to tracing prescription drugs at the package level.
The meeting started off with short presentations by representatives from:
- Biotechnology Innovation Organization (BIO)
- Association for Accessible Medicines (AAM)
- Healthcare Distribution Alliance (HDA)
- National Association of Chain Drug Stores (NACDS)
- American Pharmacists Association (APhA)
In the short time they were each given, these speakers Continue reading FDA DSCSA Public Meeting #1 Exposes Gulf In Goals
FDA Announces New DSCSA Pilot Program and Public Meeting Series
Yesterday the FDA published a preview of two announcements related to the Drug Supply Chain Security Act (DSCSA). One was announcing a new pilot program, “…to assist in development of the electronic, interoperable system that will identify and trace certain prescription drugs as these are distributed within the United States.” That is, the system that will comprise the “Enhanced Drug Distribution Security” (EDDS) system in 2023. The other announcement was for a series of DSCSA public meetings—also intended to work on the system in 2023. Both announcements include a docket for use by stakeholders and the public to submit written comments to the FDA. Continue reading FDA Announces New DSCSA Pilot Program and Public Meeting Series
FDA Forfeits Opportunity To Guide Industry
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
FDA To Hold DSCSA Public Meeting
The FDA is almost 10 months behind in the release of guidance documents for the Drug Supply Chain Security Act (DSCSA) as scheduled by Congress (see “FDA DSCSA Deadline Passes Quietly”, “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”, “FDA Speaks At GS1 Connect”, and “FDA Plans Busy Second Half of 2016 With Six DSCSA Draft Guidances Expected”). So far this year the FDA has held one public meeting to collect public and stakeholder input on the pilot that the law mandates (see “FDA To Hold DSCSA Pilots Workshop”, and “The 2016 FDA Pilots Workshop”). The DSCSA requires the FDA to hold at least five public meetings “…to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment.”
This morning, the FDA announced Continue reading FDA To Hold DSCSA Public Meeting
FDA’s DSCSA Guidance in 2014
When Congress penned the Drug Supply Chain Security Act (DSCSA) last year it laid out specific dates and subjects for which it expected the FDA to publish guidance on. So far in 2014, the FDA has kept up with that schedule by holding a public meeting, publishing multiple draft guidances and setting up a website to collect information from wholesale distributors and third-party logistics providers.
The public meeting was held on May 8th and 9th to collect ideas for the standards that FDA should support for the interoperable exchange of transaction data in paper and electronic form, starting with manufacturers, repackagers and wholesale distributors on January 1, 2015 and dispensers on July 1, 2015 (see “The 2014 FDA DSCSA Workshop“). During the workshop, the attendees raised Continue reading FDA’s DSCSA Guidance in 2014