The OGD had some late-month stocking stuffers as it issued 68 full-approval actions and 16 tentative-approval actions for a total of 84 approval actions in December. Despite the hectic holiday schedule, if these numbers are confirmed in the official totals for the month, it would mean that the OGD managed to tie the second highest […]
The logbook is the original audit trail mechanism as predicated in Eudralex, Volume 4, Chapter 4, Section 4.31. Is it too simple to automate or are we addicted to the simplicity of using them? Regardless, the industry struggles to automate the review of one of the simplest controls. In 2024, there were twenty-nine inspectional FDA 483s due to the […]
According to Fraiser Kansteiner’s article published on January 2, 2025 in Fierce Pharma (here), “Lilly on Wednesday filed a motion to intervene in a lawsuit brought by compounding industry group the Outsourcing Facilities Association (OFA) and compounder FarmaKeio Custom Compounding in U.S. District Court in Fort Worth, Texas.” As so the saga goes on. Lilly is […]
The Code of Federal Regulations at 211.110 is titled “Sampling and testing of in-process materials and drug products.” This new draft guidance, issued by the FDA, is designed to assist drug product manufacturers in complying with this section of the regulations “to ensure batch uniformity and drug product integrity. In addition, this guidance discusses related […]
Twice a year, the FDA publishes an update of the List of Off‑Patent, Off‑Exclusivity Drugs without an Approved Generic (see the December 2024 listing here). This list is designed to generate interest from the industry in increasing competition among such products and it is made up of two parts. Part I is for drugs for which […]
Just a week or so ago, there was a significant concern raised regarding the use of buprenorphine in chronic opioid use disorder (OUD) and the development of severe dental caries that occurred in a number of patients who previously had no history of increased caries prior to the start of therapy for OUD (see here). […]
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 […]
An aspect of contamination control is the assurance that residual material is not carried over into successive batches by incomplete cleaning of equipment. Cleaning procedures (both the cleaning process and the analytical method to verify cleaning effectiveness) to provide this assurance should be validated. Sampling of equipment for the purpose of cleaning validation or cleaning […]
As of December 15, 2024, just seven business days before Christmas, the OGD has issued 23 full-approval actions and 11 tentative-approval actions. With the holiday quickly approaching and facing what is likely a full FDA vacation schedule, what will the end of the month look like? A total of 34 full and tentative approval actions at […]
