As many in industry are already aware, suitability petitions began to be subject to review metrics at the beginning of Fiscal Year 2024, which started on October 1, 2023. As a reminder, the GDUFA III Commitment Letter (GIII CL) requires the FDA to review and respond to suitability petitions that have been assigned a goal date within six […]
The holidays are fast approaching and many of us are in a joyful spirit, more prone to giving and charity in alignment with the season. That said, considering the effort that goes into sponsors’ pursuit of ANDA approvals where the sponsor or sponsors may be eligible for 180-day exclusivity, I doubt that anyone in the […]
For those of us that live in areas with seasonal changes, I’m sure everyone has experienced the telltale signs that autumn is right around the corner. These changes are subtle at first but soon gain significance and portend a future that looks different than the present. Individuals who carefully examine the FDA’s Paragraph IV (PIV) Patent […]
In a recent landmark decision, the Supreme Court struck down what is known as the Chevron decision, a 1984 case that basically gave federal agencies deference in how to interpret statutes that may be somewhat ambiguous or not completely clear. This deference was not, of course, absolute (as we will see later), but, basically, under […]
Any frequent reader of the Lachman blog is well acquainted with the blog’s affinity for commenting on approval metrics from the Office of Generic Drugs (OGD). Today’s blog will also address metrics, but, in this case, the metrics are related to suitability petitions and are completely unofficial as the OGD has yet to publish or […]
As one would expect from a consulting service that focuses primarily on the Regulatory and Compliance sectors, the Lachman Blog has not historically focused on issues that are primarily economic in nature, unless the discussion is related to drug shortages. When searching our blog archive, I only found a single reference to the issue that […]
Last week, I was able to attend SBIA’s Generic Drug Forum in Bethesda, Maryland, and I’m sure that many readers of Lachman’s blog also attended virtually. The Forum offered a diverse array of presentations applicable to the generic industry at large. In this blog, I will focus on one presentation related to PLAIRs (Pre-Launch Activities […]
If there was one theme that was pervasive throughout the discussions and presentations at the recent AAM Access 2024 meeting in Tampa, Florida, it was related to drug shortages. The issue was touched upon by representatives from AAM, officials from the FDA, CEOs, Doug Long of IQVIA, and others as well. With different individuals providing […]
I last wrote about the topic of ANDA Suitability Petitions (SPs) in August 2023. At the conclusion of that blog post, I referenced an SP response that had been issued in April 2000 for a SP that was submitted in November 1999, which amounted to completed review and response by the FDA in less than […]
With summer in full swing and many people on vacation or thinking about their upcoming vacation, I decided to look forward to the fall and an upcoming GDUFA commitment on Suitability Petitions (SP) that begins on October 1, 2023. But first, let’s look back on events related to SPs in Calendar Year (CY) 2023. Earlier this year, […]
