Tag Archives: FDA Public Meeting

DSCSA

FDA DSCSA Public Meeting #3: A Difference?

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Last Wednesday the FDA held the third in a series of three Drug Supply Chain Security Act (DSCSA) public meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  I noticed a few important differences at this meeting compared with the two previous meetings (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”, and “FDA DSCSA Public Meeting #2, Still A Gulf”).

Overall, these differences indicate that the FDA may be beginning to recognize how much ground they and the industry must cover between now and November of 2023, and it appears that has led them to get a little more rational.  One meeting is not enough to establish a change in pattern, but if it eventually proves true, then this meeting would be the beginning of that change.  A big injection of rationality is what happened in Brazil back in late 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”) and that seems to have put them on a course for success.  Could something similar be happening here? Continue reading FDA DSCSA Public Meeting #3: A Difference? →

DSCSA, FDA

2018: The Year of FDA DSCSA Public Meetings

Happy New Year, 2018 is here!  Last year, the FDA announced a series of three Drug Supply Chain Security Act (DSCSA) Public Meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  So far they have held two (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”).  One more is left in that series, to be held on February 28, 2018. Continue reading 2018: The Year of FDA DSCSA Public Meetings →

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FDA DSCSA Public Meeting #2, Still A Gulf

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The gulf in expectations and goals exposed in the first FDA Drug Supply Chain Security Act (DSCSA) Public Meeting back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “HDA Schools FDA On DSCSA”) was still visible in the second meeting last week.  There is still one more announced meeting scheduled for February 28, 2018 for the FDA and the industry to align (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”).  Based on my observations at these first two meetings, I’m not going to hold my breath.  The FDA is likely to announce more meetings in 2018.

The FDA did adjust their position on at least one thing after the August meeting. Continue reading FDA DSCSA Public Meeting #2, Still A Gulf →

DSCSA

Sponsored: FDA DSCSA Public Meeting Q&A

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 →

Conferences

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 →

DSCSA

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:

In the short time they were each given, these speakers Continue reading FDA DSCSA Public Meeting #1 Exposes Gulf In Goals →

FDA

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

FDA Forfeits Opportunity To Guide Industry

fda-building-2016-10-14-16-38-20I 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 →