The recent bankruptcy announcement of 23andMe is a classic case study in data ownership – not necessarily what should happen, but what actually does happen! Open and transparent discussion about data ownership is sometimes easier if the situation is not strictly a GxP issue, but the learnings and analogies in a QMS or PQS should […]
In April 2018, whilst I was still an expert Inspector at the MHRA, I wrote a blog on vapour hydrogen peroxide. Having recently joined Lachman Consultants, I thought it would be an ideal time to revisit this subject to understand the current situation with this method and perhaps provide insight as to what Lachman could […]
As we approach the last week in March, we now have one-third of FY 2025 behind us. January’s ANDA approval numbers continue to look good, as we discussed in our February 6, 2025 post on the unofficial January approval actions (here). Another month with 90 total approval actions is good news for industry. The monthly total is […]
The old saying “March comes in like a lion and goes out like a lamb” might apply to March 2025 as the OGD has issued 34 full-approval actions and 17 tentative-approval actions through March 17th. The biggest day was the first business day of March when the OGD pushed out eleven full- and four tentative-approval […]
After a March 6, 2025 report from an independent testing facility claimed that a significant number of acne products containing benzoyl peroxide were found to have very high levels of benzene (here), the threat has been countered by the FDA’s own testing of 95 products. After the FDA’s testing results were confirmed, it announced that the “FDA […]
Today, I read an article in Dickinson’s FDA Webview (here; subscription required) titled “Clinical Researchers Plead Guilty to Fraud” that has the following rather chilling opening line: “Two clinical research facility owners plead guilty in Florida federal court to conspiracy to commit wire fraud in connection with their work on two clinical trials testing drugs […]
An Endpoints News story authored by Shelby Livingston titled “Compounders’ motion for preliminary injunction denied in case over tirzepatide shortage” (here; subscription needed) appears to give this round of the fight to declare the tirzepatide drug shortage over to the FDA. The Honorable Mark Pittman, U.S. District Court for the Northern District of Texas, denied […]
“Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs with a competitive generic therapy designation under section 506H of the FD&C Act.” These […]
The OGD unofficially issued 53 full approval actions and 16 tentative approval actions for a total of 69 approval actions. For a month with only twenty-eight days and one federal holiday, the OGD’s approval-action total is not too bad. Coupled with the great uncertainty regarding terminations and reduction in force of CDER employees, I think […]
Almost two months to the day, the OGD published its final December statistical report along with the Quarterly Report on approval times for the first three months of FY 2025. It appears that the OGD did better in ANDA approval and tentative approval (TA) actions than we had reported back on January 6, 2025 in […]
