Did you ever REALLY wonder what is being done by our federal government and other stakeholders to combat the current drug shortage situation? This past June 12th, representatives from various government agencies as well as industry leaders and the Duke-Margolis ReVAMP Drug Supply Chain Consortium (with yours truly participating on the expert panel) met to […]
Now, don’t get too excited as this likely will not apply to you (see below for more detail for non-small dispensers)! The FDA expects all entities to be fully compliant with the Drug Supply Chain Security Act (DSCSA) by November 27, 2024; however, there are certain exemptions for what the Agency describes as “small dispensers” that […]
The current state of drug shortages in the supply chain is under continued pressure, both outside of and within the U.S. According to the FDA, there are currently 105 products in shortage in the U.S. (here) as of the drafting of this blog. Not only are the shortages continuing, but adherence to section 506C of the […]
The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem. The latest communication is titled “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here). This is a deep dive […]
Lachman Consultants (Ireland) will participate at this year’s PDA Quality and Regulations Conference in Antwerp, Belgium, November 7 – 8. The two-day in-person event will cover a wide range of topics related to regulatory and industry best practices, with a particular emphasis on addressing shortages and enhancing supply chain resilience. Lachman Consultants (Ireland) will be […]
Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]
The “race to the bottom” for cost and the cumulative effect of “lean-out” global supply chains have had an unintended consequence for the safe, reliable supply of product. Third-party management has become a growing and recognized risk. And then there’s fourth- and fifth-party management. They are all-important parts of supply chain challenges in today’s increasingly […]
Join us September 28th, 2023, at 10:00 AM EDT for A Lachman Learning Experience. Where are you on your Annex 1 journey? Have you created a measurable plan for progress? Assess your current position and start making plans for the future by attending this highly informative and valuable webinar. Join Lachman Consultants’ Executive Director Keith […]
On August 25, 2023, the Office of Generic Drugs approved a total of 14 different applications for lisdexamfetamine dimesylate products after the expiration of a patent on August 24, 2023. (This is the first time in a long while where I remember this many applications being approved on a single day.) While this is good […]
Many of our blog readers have likely encountered moving goal dates for their ANDAs since October 1, 2022 and the beginning of GDUFA III. The GDUFA III Commitment Letter, available here, included several new enhancements to the generic drug user fee program as each iteration of the program has continued to do. The changes made to promote transparency […]
