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As discussed in a recent Lachman blog Revised Q1 Draft Stability Document Issued by FDA, the draft guidance titled Q1 Stability Testing of Drug Substances is a consolidated revision of ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C. This draft guidance provides guidance on product categories, such as advanced therapy medicinal products, vaccines, and other […]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 […]
On June 25, 2025, Reps. Sherrill and Harshbarger reintroduced a bipartisan bill to modernize prescription information (here) and, on June 12, 2025, two senators introduced a similar bill in the Senate (see previous post here). Now we have very similar bills floating around in each chamber. Maybe this is the year that the legislation will pass […]
The newly revised and expanded draft guidance titled Q1 Stability Testing of Drug Substances and Drug Products (here) was published today. This draft guidance represents “a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May 1997, January 2003, June 2004, and July […]
An Associated Press article (here) reported that “Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months.” This would be accomplished by a team of reviewers similar to those formed under Operation Warp Speed for approvals of the COVID-19 vaccines. “Makary said he will […]
Now, here is a head scratcher. According to the Pink Sheet article written by Sue Sutter (here), “The White House requested $6.76bn, a decrease of 3.9%, or $271.5m, from the FY 2025 funding level. The proposal includes $3.17bn in budget authority, a decrease of 11.4%, and $3.59bn in user fees, a 4% increase.” What a dandy, […]
