On Day 2 of the Generic Drugs Forum (GDF), there were a couple of sessions on Drug Master Files (DMFs) that provided some helpful information. The first presentation, from Dr. Jayani Perera, Senior Chemist in the Division of Product Quality Assessment (DPQA) XIX, provided some insight into the GDUFA III impact on DMF Assessments and DMF Prior Assessments (watch […]
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 […]
Firms will commonly espouse the virtues of a robust company culture as it relates to Quality. I’ve frequently heard the chant that “culture trumps strategy” when addressing the need to drive quality improvement plans. There’s a lot of credence with such a statement as culture is addressing (at a high level) a collective belief with […]
Lachman has blogged many times on the topic of nitrosamines over the last several years as the FDA has issued and revised guidances providing its recommendations for assessment and control of nitrosamine impurities. The published deadline for compliance with these recommendations is quickly approaching; it’s just over three months until the August 1, 2025 compliance date […]
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 […]
As you will all be aware, EU GMP Volume 4 Annex 1 and PIC/S Annex 1 (hereinafter referred to Annex 1) for “the manufacture of sterile medicinal products” was published in August 2022 and the majority of the guidance came into force in August 2023. One of the key elements of the guidance was the introduction of Quality […]
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 […]
