On April 29, 2026, the FDA published a notice in the Federal Register (FR) (posted on the FR prepublication page (here)) announcing the FDA’s intention to withdraw approval of the New Drug Application (NDA) for TAVNEOS (avacopan) capsule, 10 milligrams (mg), held by ChemoCentryx, Inc. and offer the applicant an Opportunity for a Hearing regarding the FDA’s […]
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 […]
The second day of the Generic Drugs Forum provided a significant amount of new and rehashed data, including explanations and suggestions regarding certain application submission issues, including but certainly not limited to DMFs, data integrity and the ongoing nitrosamine saga. Here are a few of the helpful hints presented: When providing amendments to DMF, the […]
The FDA’s April 2, 2026 Warning Letter to a cosmetics company marks a defining moment for the regulated industry, not because artificial intelligence (AI) was used in this firm’s operations, but because it was deployed without effective governance within a Pharmaceutical Quality System (PQS). In this case, management relied on AI agents to draft GMP-critical regulatory […]
In this blog, I often rail about how unapproved drugs and illegal dietary supplements find their way into the U.S. market through the internet or mail outlets. I’ve wondered why the FDA is not doing more to stop the game of whack-a-mole where, as soon as the FDA makes an enforcement action against one supplier, […]
FDA inspectors continue to link equipment maintenance issues to data integrity problems, contamination events, and preventable batch failures. While maintenance activities are often carried out by Engineering, regulators consistently expect the Quality Unit (QU) to exercise meaningful oversight over this action. EU GMPs mirror this expectation, and industry frameworks like ICH Q10, highlight why this oversight […]
While perusing the current USP <11>, USP Reference Standards, which became effective on December 1, 2025, it was noted that the USP Reference Standard description was amended to state “highly characterized physical materials or digital data demonstrated to have the appropriate qualities to support their intended use as references for comparison in compendial tests.” The General Chapter […]
There’s always a certain energy at PDA Week – the kind that comes from a shared sense that our industry is moving, sometimes faster than we expect. This year in Denver, that energy felt different. More focused. More urgent. And in many ways, more practical. As both an exhibitor and attendee representing Lachman Consultants, I […]
Today, the FDA issued yet another health warning regarding an unapproved sexual enhancement product marketed as an over-the-counter drug and, boy, is this one a doozy. It contains sildenafil and tadalafil, the active ingredients in approved Viagra and Cialis, while also containing, flibanserin, which “is the active ingredient in Addyi, an FDA-approved prescription drug used […]
Mergers and acquisitions in the pharmaceutical industry are nothing new. CDMO consolidation has become prevalent over the last several years as well. More recently, however, a new and more complex dynamic has emerged: pharmaceutical companies acquiring CDMOs outright. A pharmaceutical company acquiring a CDMO represents more than financial consolidation. It fundamentally reshapes the quality, compliance, […]
