We love reading other regulatory pieces, and particularly liked the one written by Regulatory Focus’ Michael Mezher (here) concerning the “agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.” While this may provide a better focus for the FDA to coordinate efforts through CDER resources, it could also mean a […]
In our post from June 10, 2019 (here), we commented on an apparent revision in the number of approved ANDAs from the month of April (a change from 98 to 93). While scratching our heads about the apparent discrepancy, the FDA’s Kristofer Baumgartner, M.A., Director, Division of Public Education and Outreach, came to the rescue […]
The pre-publication page of the Federal Register Notice posted today (here) a reopening of the comment period for the draft guidance Quality Considerations for Continuous Manufacturing which was originally released February 27, 2019. That guidance can be found here . While some (but not too many) firms have embraced the concept of continuous manufacturing, others […]
Late Friday afternoon, OGD updated its reported metrics for the month of April. Below are the highlights of the new data that was reported. You can review the entire report on the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) For the third month in a row, OGD refused-to-file (RTR) 6 […]
For the first time this fiscal year (FY), it looks like the OGD will have taken fewer than 100 total final and tentative “approval actions” in a month. While we await the official OGD figures (which should be reported sometime next week), so far, for May, as gleaned from the FDA “All Approvals” page (here), […]
In today’s prepublication of the Federal Register Notice entitled Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain (here), the Agency is opening a docket to receive comments on a requirement to blister package certain commonly prescribed opioid products in an effort to reduce the potential for over dispensing quantities […]
This is a song I have sung in my house for 48 years on June 11th but now I finally get some help from the federal government! The story was all over the news this week about how Americans waste a ton of money disposing of perfectly good food because of an arbitrary date. A […]
(Westbury, NY – May 2019) Lachman Consultant Services, Inc. (“Lachman Consultants”), a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide, will be participating as a Conference Sponsor at the 25th annual Medicines for Europe and IGBA Conference. Entitled “Committing to Global Health – Balancing Access and Sustainability,” this […]
The list, published by the Office of Management and Budget, outlines a host of proposed and/or final rules the FDA “hopes” to publish, or at least consider, in 2019. Given the state of and the bent towards new or additional regulations in the current administration, this seems like an ambitious agenda for the Agency. The […]
This post was co-authored by Thu Truong, J.D., Senior Associate, Science and Technology Group, and Ron George, Ph.D, Director, Science and Technology Group Prior to USP 42 – NF 37 (effective April 30, 2019), USP Chapter <197>, Spectroscopy Identification Tests, stated, “The IR absorption spectrum of a substance, compared with that obtained concomitantly for the […]
