I guess this is the next step in the evaluation of what we can expect regarding proposals for future regulations. Semiannual regulatory agendas, along with tentative timetables, are published twice a year (as the name implies) to outline regulations that each agency is planning on issuing for those regulations. Today, in the pre-publication of the […]
There were a lot of great speakers at Access 2025, the Association for Accessible Medicines (AAM) annual meeting held from February 3rd to 5th. Here are a few of some of the most interesting topics that were discussed in fireside-chat formats. John Murphy III, President and CEO of AAM, posed questions to Alex Azar, former Secretary, […]
Powered up my laptop this morning and guess what I found? ANDA, NDA, and BLA approval actions had been updated from their last postings on January 22, 2025 after the pause on communications from the FDA. The best news is that January 2025 ANDA approval actions look great. As of today, the OGD has posed 64 […]
“Disruption” was the common theme expressed by many panel members at this year’s Access 2025 meeting of the Association for Accessible Medicines in Amelia Island, Florida. In speaking to attendees, “I just don’t know what to expect” seemed to be the mantra of the day. The absence of FDA attendees also seemed to shake the […]
There are a few items I’ve seen that give me hope that the communications ban may be coming to an end soon. However, there are still some mysteries in the ban that confuse me. For instance, there have been no approvals listed on the CDER webpage (here) since January 22, 2025. But today, for the first […]
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 […]
In the latest CDER Science Spotlights, available (here), the FDA provides some insight into the development of the Carcinogenic Potency Categorization Approach (CPCA) to determine recommended acceptable intake limits of N-nitrosamine impurities in drug products. The latest revision of the Nitrosamine Impurity guidance updated in September 2024 (here) provided better integration of the overall assessment […]
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 […]
