This month, April 2026, the Center for Drugs Evaluation and Research’s (CDER’s) Office of Compliance (OC) issued its yearly report, highlighting many of its goals, new programs, and accomplishments. First, let’s take a look at the report by the numbers. According to the report (here), the OC lists the following workload figures: Office of Compliance […]
Congratulations! Your firm has just successfully manufactured a high-quality pharmaceutical or biological product and is ready to ship it to the next destination to get it into the hands of the people who need it. Take a moment… is your firm REALLY ready? Your firm’s product is either starting its journey in a global supply […]
The FDA’s current drug shortage list (here) contains 93 entries with 10 of those entries being for drug shortages that are resolved. This means that the FDA currently lists 83 drugs that are actually in shortage. The American Society of Health-Systems Pharmacists (ASHP) listing (here) currently reports 222 drug shortages. Why is there such a […]
In a July 24, 2025 FDA alert (here) citing the danger of benzene contamination in certain drug ingredients and drug products as well as various excipients such “as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons, or to degradation of certain active ingredients in drug products” that could lead […]
How is your company reacting to threats in its supply chain and transforming risk into opportunity? In a mature application of Quality Risk Management (QRM), companies should lean into the political winds of “onshoring,” “nearshoring,” and “friendshoring” as these concepts have been stood up as well-discussed risk mitigations to the current drug shortage problems. These […]
Lachman Consultants has continued its active engagement with efforts to combat the global drug supply chain shortages. Despite the FDA’s significant success in helping to prevent 236 drug shortages in 2023, the problem persists and may be about to get worse. The current problem, external environment, and emerging risks are highlighted in a recent publication […]
On December 19, 2024, the FDA finalized its reexamination of its initial decision (on October 2, 2024) that the tirzepatide shortage had been resolved. This comes after compounders of the drug ran to court to challenge the Agency’s initial decision. The latest notice of the shortage’s resolution came yesterday in a declaratory letter (here), issued by the […]
The Generic Drug Cluster is a consortium of top regulatory agencies from around the world that get together to discuss common issues related to the drug approval process in an effort to better understand how each agency approaches various topics. Hopefully, these discussions will result in developing regulatory strategies that reflect the best and most […]
While I can’t remember how many of these meetings I have attended over my 40 years, so far this rates with the best of them for a couple of reasons. AAM’s new President and CEO, John A. Murphy III, and we got to meet him for the first time. We profiled John in a previous […]
Though the FDA had indicated previously that it would not extend the deadline for full implementation of Drug Supply Chain Security Act (DSCSA) requirements, discretion appears to have become the better part of valor. On June 13, 2024, we posted a blog about waivers that would be available for certain small dispensers, and yesterday the FDA […]
