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 […]
What do a cup of cappuccino and sterile water for injection have in common? At first glance, there is no apparent correlation, except when you become “data curious” and take the macro view of the current convergence of economics, compliance, and maturation of risk management. Sometimes utilizing existing data is the best way to understand […]
The beautiful country of Malta was the backdrop of the 28th Annual Medicines for Europe Conference for 2023. One of the key themes of the conference was assuring a consistent supply of essential medicines to all of Europe. This topic was at the heart of all the sessions. Pharmaceutical manufacturing in Europe has a rich […]
Are your supply chain weaknesses putting patients at risk of not receiving safe, reliable medicines? This could be a difficult self-reflection for weak supply chains, devastated by the pandemic. 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 […]
The Agency today published four draft guidance documents to assist sponsors to better understand the terms and conditions of certain aspects of the Supply Chain Security Act requirements. The draft and final guidances are as follows: Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act – This […]
On February 4, 2020, FDA issued a press release regarding the issuance of an emergency use authorization (EUA) (here) to allow for emergency use of a Coronavirus diagnostic panel by Centers for Disease Control and Prevention (CDC)-qualified labs across the country. Previously, the panel’s use was limited to only CDC laboratories. This additional step […]
