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The newly revised and expanded draft guidance titled Q1 Stability Testing of Drug Substances and Drug Products (here) was published today. This draft guidance represents “a consolidated revision of the ICH Q1A(R2), Q1B, Q1C, Q1D, Q1E, and Q5C series of stability guidances, published November 2003, March 1996, May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, […]
Ever since the first patent settlements after the Drug Price Competition and Patent Terms Restoration Act was signed, many of us in the generic world (and now in the biosimilar world) have suggested that most patent settlements are pro-consumer as they can bring generic products (and now biosimilars as well) to market years before the […]
Biological Product Deviation Reports (BPDRs) are coming into increasing focus during FDA inspections. The FDA commonly requests an understanding of a site’s BPDR process and examples of BPDRs submitted to the Agency. Furthermore, during the inspection and during evaluation of distributed licensed product, FDA investigators will evaluate “How,” “Why,” and “When” a firm determines the […]
Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust. Imagine […]
Given all that’s happened with the federal government this past week, it’s no wonder that we’re not hearing much from the OGD. Communications appear to be quite slow to appear. Even the Federal Register prepublication page has few FDA postings over the last three weeks. Another instance of communication lapse: since March 7, 2025, only safety […]
April Fool’s Day was a difficult day for many FDA employees, because that was when many of them found out they were let go as they attempted to enter FDA’s White Oak HQ by swiping their badges at the entry gates. With many significant Offices and Division cuts, there are questions of how those cuts […]
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 […]
