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 […]
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 […]
As consultants we have the privilege of assisting many clients with FDA communications on a variety of topics and working with them to support many different types of drug product applications. Through our work we often identify common themes or issues that our clients are facing and one of the biggest headaches for our ANDA […]
There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]
At the Association for Accessible Medicines (AAM) Annual Meeting (aka Access! 2025), the Science and Regulatory Affairs Working Group met on February 3, 2025. This session is always a highlight, and one of my favorite sessions, offering insight into key regulatory and scientific issues that the AAM is currently tackling as well as those that it […]
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, […]
“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 […]
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 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 […]
