Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA. Are you among the many […]
Sidley Austin LLP filed a petition (here) requesting that FDA not grant orphan drug exclusivity to a ready-to-use version oral solution of vigabatrin. There are currently two versions of vigabatrin already approved with a number of generics available. The original approved NDA products (tablet and power for reconstitution) were granted orphan drug exclusivity (ODE), the […]
First, let’s look at September 2023 statistics (end of FY 2023), then we will comment on the full FY stats. As we reported here, September looked to be a slow month, and it was. While we missed a few full-approval actions (we reported forty-one), the OGD actually issued forty-four, and ten tentative-approval actions. Remember, the Agency […]
In case you didn’t have the opportunity to attend the GRx+Biosims 2023 conference or were there and want to revisit the featured panel on nitrosamine impurities, here’s a quick recap and a link to the full Contract Pharma article, authored by Jennifer Leaming, Principal Consultant, Lachman Consultants. Four presentations were made by FDA representatives on […]
Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]
Well, folks, it looks like the FDA got its ANDA approval posting computer glitch fixed, but even that does not seem to guarantee good news. The FDA issued forty-one full-approval actions and ten tentative-approval actions for (an obviously low) total approval actions of fifty-one. That is the lowest number of full-approval actions since December of […]
Another beautiful fall day in Bethesda and a great start to this year’s conference. Since I can only be in one place at a time (although my wife would beg to differ), I will give you some highlights from day 1. And next year, you should attend this meeting as this is the premiere event for […]
Join Lachman Consultants at GRx+Biosims™ 2023 in North Bethesda, MD, Oct 2 – 4 for three days of insights and engaging discussions around the most pressing issues vital to the generics and biosimilars industry. Lachman will be represented by several members of the team, including: Frances Zipp, President & CEO Bob Pollock, M.S., Outside Director […]
Earlier this week, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry” (here). Although the Draft is still out for comments, it gives us a behind-the-scenes look at the FDA’s use of proposed “alternative tools” in conducting remote-based inspections. The proposed Guidance […]
The “race to the bottom” for cost and the cumulative effect of “lean-out” global supply chains have had an unintended consequence for the safe, reliable supply of product. Third-party management has become a growing and recognized risk. And then there’s fourth- and fifth-party management. They are all-important parts of supply chain challenges in today’s increasingly […]
