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 […]
In the quest for effective treatments for their disease, cancer patients often require several different modalities and treatment types. Radiopharmaceutical products are one of those forms of treatment, and treatment with these types of products requires expedient delivery to ensure that the required dosage is administered to patients as radioactive decay may result in a […]
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 […]
When a firm receives an FDA 483 finding of “does not follow Standard Operating Procedures (SOPs) for performing X GMP activity,” the immediate response is often to revise or update that specific SOP with more detailed instructions. While this might seem like the right thing to do for a quick fix, it is crucial to […]
In a prepublication Federal Register notice (here), it was announced that the final rule “Nonprescription Drug Product With an Additional Condition for Nonprescription Use” has had its implementation date delayed until March 21, 2025. According to the notice, the “FDA published a final rule, titled ‘Nonprescription Drug Product With an Additional Condition for Nonprescription Use,’ in […]
A few months ago in this blog, we discussed the suitability of analytical methods and how a firm needs to demonstrate that a method is fit for purpose and, with that determination, there needs to be an understanding of the measurement uncertainty (MU) associated with the reported results (from that method). This blog can be […]
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 […]
