Given all that’s happened with the federal government this past week, it’s no wonder that we’re not hearing much from the OGD. Communications appear to be quite slow to appear. Even the Federal Register prepublication page has few FDA postings over the last three weeks. Another instance of communication lapse: since March 7, 2025, only […]
April Fool’s Day was a difficult day for many FDA employees, because that was when many of them found out they were let go as they attempted to enter FDA’s White Oak HQ by swiping their badges at the entry gates. With many significant Offices and Division cuts, there are questions of how those cuts […]
On March 28, the FDA issued a notice (here) informing pharmaceutical companies that have submitted in vitro and in vivo bioequivalence studies in applications that were conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based in Navi Mumbai, India, that it has “identified significant data integrity and study conduct concerns” in certain studies in […]
Now that Dr. Marty Makary, MD, MPH, has been confirmed and appointed as FDA Commissioner, much of the Agency does not look the same. The morale at the FDA, from what I hear, is at an all-time low. And now, with reports of the reduction in workers’ safeguards along with actions as to what appears […]
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 […]
In a pre-publication notice in the Federal Register today (here), the decision on the issuance of the rule will be kicked down the road another sixty days until May 21, 2025 so the FDA/administration can fully vet the rule. This is the second delay since it was published as “a final rule, titled ‘Nonprescription Drug Product […]
The over-the-counter monograph drug facility (OTC MDF) fees for FY 2025 are effective on October 1, 2024, and fees will be due on June 2, 2025. There are two types of facility fees for OTC drug manufacturing facilities: An OTC MDF is a foreign or domestic business or other entity that, in addition to meeting other criteria, 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 […]
