While passage of the Continuing Resolution by Congress on September 30, 2022 and corresponding reauthorization of user fees for the different programmatic areas is a relief, the extremely late passage of the Bill leaves FDA and Industry in an awkward position in relation to one of the most important elements of the reauthorization-submission of applications […]
All indications seem to be that all the User Fee reauthorizations (loving known as the UFAs) will be passed in a fairly clean bill by the end of the week. This is great news for FDA employees and for industry; however, we sure hope that they tell us what to do as that will basically […]
The Center for Drug Evaluation and Research (CDER) approved 50 novel therapies in 2021 which are described in a recently released 26-page report (here) that discusses in some detail the 50 novel products and their bearing on treatment for patients. The report discusses the mechanistic pathway for approval and provides a list of all the […]
Covering a multitude of subjects, the Agency published eight new guidance documents ranging from the ICH M9 BCS classification system to a Q&A document on qualified infectious disease designations. Here is a list of the eight guidance documents. M9 Biopharmaceutics Classification System-Based Biowaivers (here) E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis […]
As we all know, the pandemic has wreaked havoc with inspections of drug manufacturers, API manufacturers, and laboratory facilities, as well as inspection of clinical study sites. Remote working, meeting problems, and just general pandemic fatigue has hindered some of the FDA’s work. However, the statistics are not as bad as one might think, all […]
On Tuesday, July 21, Mary Oates, Ph.D., Vice President, Compliance Services, will be participating in a webinar organized by Informa, publishers of the Pink Sheet and Scrip. Mary will be a panelist in a session on Virtual Drug Inspections, occurring at 2 PM EST. The entire webinar series, which is taking place over a 24 […]
Well, here we are. We’ve crossed the transition date (i.e., March 23, 2020) and now the New Drug Applications (NDAs) for the biologic products that were approved by FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA) should now be deemed to be Biologic License Applications (BLAs). According to the FDA’s website, a total […]
As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]
The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here). A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]
Today, the FDA published in a final rule (here) a significant revision to the regulatory definition of biological product that will have a major impact on what product will be regulated under the Public Health Service Act (PHSA), and which will be regulated solely under the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, the […]
