The proposed revision to USP <1058> introduces a significant change in the approach to analytical instrument and system qualification (AISQ). Instead of considering qualification as a series of isolated events, the updated chapter adopts a risk-based life-cycle approach that encompasses the entire life cycle of an analytical instrument—from specification and selection through installation and performance verification […]
With the first (albeit unofficial) count of ANDA approval actions since the layoffs at the OGD, the future does not appear bleak. At least not yet! The postings through April 16th for approval actions show that the OGD has issued 43 full-approval actions and five tentative-approval actions for a mid-month total of 48 approval actions, which […]
On Day 1 of the Generic Drug Forum, the topic of submitting a Request for Reconsideration (RfR), as first provided for in GDUFA II and updated in GDUFA III, was presented. The FDA’s Office of Generic Drugs (OGD) had two presentations on this topic, one from Joe Shin, PharmD, and one from Dr. Yi Zhang. In his presentation, Dr. Shin […]
The Generic Drug Forum was a two-day event held on April 8-9, 2025. This was one of the first public engagements that the Office of Generic Drugs (OGD) participated in since the current administration’s pause on FDA communications was announced in February 2025. There were many interesting sessions that presented an enormous amount of content. […]
Presentations for the Generic Drug Forum, which was held in person and virtually on April 8-9, provided a look at the Office of Generic Drugs’ compliance with Fiscal Year (FY) 2024 User Fee goals for review of applications and supplemental applications. The OGD has met all of its review objectives from the GDUFA commitment letter for […]
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 […]
It has been quite some time since issuance of the GDUFA III commitment letter, which discussed a few new enhancements to the ANDA review and approval process, among other things. One such enhancement was Imminent Action (IA). Just to refresh your memory, an imminent action is an extension of the goal date when the Office of […]
On April 10, U.S. Senators Maggie Hassan (D-NH), Rand Paul (R-KY), John Hickenlooper (D-CO), and Mike Lee (R-UT) reintroduced bipartisan legislation S. 1302 that would prevent the FDA and industry from participating in a protracted guessing game regarding the amount of an inactive ingredient for a subset of generic drugs that are either required by regulation […]
So, after Monday’s blog post, All’s Quiet On the Eastern Front (here), I woke up this morning to the first signs of at least some normality at the OGD. First, ANDA approval numbers began appearing on the Daily Approvals page and the Small Business and Industry Assistance webpage. On top of that, the first day […]
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 […]
