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 […]
At the Association of Accessible Medicines (AAM) February 2024 Annual Meeting Jacqueline Corrigan-Curay, J.D., M.D., Principal Deputy Center Director of CDER, made another interesting point in her presentation yesterday, outlining the number of national drug shortages that the FDA reported per calendar year (reproduced at the link below) and indicating that the press has reported […]
An AAM blog posted this morning (here), titled The Quickest Route to U.S. Essential Medicines Production: Existing and Idle Production Sites, seems to think that the answer to this post’s titular question is Yes, and it at least provides another option for consideration. The AAM post cites a report (here) by Professor Anthony Sardella from […]
With the United States currently experiencing shortages of Ibuprofen suspension due to an increased demand that the FDA states is caused by “a surge in three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza,” the Agency recognizes the need to establish an appropriate enforcement strategy to aid in the availability of this […]
Whether it be the supply chain, compliance issues, manufacturing issues, issues with packaging components, or just plain bad luck, the number of drug shortages continues to plague the pharmaceutical industry both domestically and overseas. The FDA current shortage list (here) contains 191 entries and, of that number, only 66 have been resolved, leaving 125 drug […]
As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]
I just read the Association for Accessible Medicines’ (AAM) White Paper entitled “Ensuring the Future of Accessible Medicines in the U.S., Avoiding Shortages & Ensuring Competition for America’s Patients” (here) that is being entered into the record at the FDA-sponsored meeting Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions held on November […]
