Today, the FDA released a draft guidance titled Conducting Remote Regulatory Assessments: Question and Answers (here). The document describes the origin of the remote regulatory assessment (RRA), its legal basis, and how it has been used, along with an explanation of the scope of its use for all FDA-regulated products. The FDA discusses the difference […]
The FDA quietly posted an update to the CDER Nitrosamine Impurity Acceptable Intake Limits webpage yesterday. The latest update is unusual in that it is not an update to any of the posted AI limits, but rather the text added below Table 4 noting that the FDA is allowing additional time for submission of required changes […]
Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.” What a dandy, […]
Airflow visualization studies (AVS) (also known as smoke studies) are an integral part of contamination control practices in GMP-controlled aseptic processing plants. As per regulatory guidelines such as the FDA’s 2004 Guidance on Aseptic Processing (here), USP <1116> (here), and PDA Technical Reports 13 (here), 22 (here), and 34 (here), these studies enable the measurement […]
Today, May 22, 2025, “[t]he U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid” (see the FDA announcement here). The two labs receiving the so-called General Correspondence Letters are […]
Ingestible fluoride products used to prevent dental caries have a long and twisted regulatory history relative to their permitted marketing status. After searching the web for an explanation, I found an interesting article (here) published by the Fluoride Action Network. I provide this article as it gives a reasonable historical account of the avenues along which the […]
We just wrapped up an engaging and insightful two days (May 6-7, 2025) at the PDA Pharmaceutical Manufacturing and Quality Conference 2025 in Singapore. As anticipated, the event delivered high-value content through impactful presentations from current and former regulators as well as seasoned industry professionals. Their thoughtful responses to audience questions added real depth to the […]
Today, the FDA announced the “Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities” (here), signaling that the Agency appears to be leveling the playing field between domestic and foreign facility inspections. According to the comments in the May 5, 2025 Regulatory Affairs Professionals Society (RAPS) Regulatory Focus article by Joanne S. Eglovitch (here), the “unannounced foreign […]
Biological Product Deviation Reports (BPDRs) are coming into increasing focus during FDA inspections. The FDA commonly requests an understanding of a site’s BPDR process and examples of BPDRs submitted to the Agency. Furthermore, during the inspection and during evaluation of distributed licensed product, FDA investigators will evaluate “How,” “Why,” and “When” a firm determines the […]
With the FDA declaring the shortage of semaglutide over and the recent development that “U.S. District Judge Mark Pittman denied the Outsourcing Facilities Association’s bid for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide, the active ingredient in Ozempic and Wegovy” (see here), […]
