As we near the end of October 2025, the first month of new FY 2026, and as FDA appropriations languish in our dysfunctional Congress, the number of fee-paying submissions submitted to FDA so far in the new Fiscal Year 2026 = 0. That’s right nada, nil, zero, zilch, none. You can count the number on […]
The Commissioner’s National Priority Voucher (CNPV) program is designed to shorten the review times of complete submitted New Drug Applications (NDAs) and Biologics License Applications (BLAs) from a standard ten months to two months. We have written previous blogs on this topic as can be seen here, here, and here and have expressed some concerns […]
The proposed legislation is welcomed by those in the biosimilar space and the FDA because for years the FDA has said that all biosimilar products, based on the current review and approval paradigm, should be considered interchangeable. The EU has adopted that position as well; however, this bill, if passed, will be the necessary legislative […]
FDA announced a new revised draft guidance which “is being updated and reissued in draft to, among other things, include the addition of information related to Congress’ 2018 changes to the definition of adverse drug experience regarding reduced effectiveness and make other changes to reflect current Agency processes and procedures regarding safety labeling changes. This […]
Priority review vouchers are awarded to the sponsors of applications for tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) products that gain approval. The new fee for use of a priority review voucher is the same for each type of voucher as identified in the table below: The pre-publication Federal Register Notice […]
As discussed in a recent Lachman blog Revised Q1 Draft Stability Document Issued by FDA, the draft guidance titled Q1 Stability Testing of Drug Substances is a consolidated revision of ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C. This draft guidance provides guidance on product categories, such as advanced therapy medicinal products, vaccines, and other […]
On July 22, 2025, the FDA announced more details on the CNPV pilot program (here), indicating that the Agency will accept no more than five applications for the first year (2025). The announcement provides a broad program overview along with key program benefits. The announcement also outlines the eligibility criteria for inclusion, stating: “Your company […]
In combing through regulations.gov this morning, I found a July 7, 2025 petition (here) submitted by a physician citing concerns about “prematurely expiring drugs.” His point is that many drugs likely would still meet all of the required specifications outlined in an application well past their labeled expiration dates, which could positively impact drug shortages and […]
In this case, it has to do with our blog yesterday (here) and the announcement of how the FDA is embracing “Radical Transparency by Publishing Complete Response Letters.” It turns out that many news outlets jumped on the story as a transformative act, as did we, only to find out that many, if not all, […]
I opened my browser this morning at 6AM PST and the first thing I saw was an FDA notice I never thought I would see. Right there on my computer, the Notice (here) said “FDA Embraces Radical Transparency by Publishing Complete Response Letters”. Yes, that’s right – CRLs are now being posted! According to the […]
