The OGD is off to a good start in 2025, with 31 full-approval actions and 14 tentative-approval actions for a total of 45 approval actions posted as of January 16. While this number is not as high as the number of Executive Orders signed by Trump in his first day back in office, if the […]
I remember when I was at the FDA and presenting at a meeting discussing a guidance that industry had been waiting for the FDA to publish for a year or so. I noted that it would be released soon! Immediately someone from the audience asked, “what’s the FDA’s definition of soon?” I thought for a […]
For those of you that have been following the saga of the attack on the skinny label, we may be getting close to a solution. Remember that a skinny label is labeling that cuts out a particular use or information protected by patent or market exclusivity of the branded product. This allows for a generic […]
The OGD published the second month of the Fiscal Year (FY) 2025 statistical report titled, Generic Drugs Program Monthly and Quarterly Activities Report (here). There is some continued good news and also some troubling news in the report. On the positive side, we previously reported (here) in our unofficial posting, the full approval actions as […]
The pharmaceutical industry is entering a transformative era with the Food and Drug Administration’s (FDA) newly established pathway for nonprescription drug products with an Additional Condition for Nonprescription Use (ACNU), with the final rule announced in a December 2024 Federal Register Notice (here). This new rule aims to broaden consumer access to safe and effective […]
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 […]
