While many in the industry have complained about the handling of controlled correspondences (CCs), the numbers of CCs submitted in a given month continues to rise as it has every fiscal year since the process was formalized under GDUFA I. Complaints of non-answers to questions, unclear answers, and just flat-out denials of acceptance of CCs […]
Answer: Who is Bob Pollock? Next week, November 9-11, the Association for Accessible Medicines (AAM) will be hosting a virtual version of the GRx+Biosims conference. As a part of it, an Orange Book Jeopardy was held between 3 Orange Book virtuosos: Kurt Karst of Hyman, Phelps & McNamara, David Rosen of Foley Lardner, and our […]
The Office of Generic Drugs (OGD) updated its April stats and notes 4 refuse-to-receive (RTR) actions (3 standard ANDAs and 1 priority application) which is in line with what we have seen so far this entire FY (months average for 7 months is 3.6 RTRs/month). OGD also acknowledged 65 new ANDAs in April. Of the […]
As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]
In earlier blogs, we have written about specific technical items related to identity testing. However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]
The FDA’s Office of Pharmaceutical Quality (OPQ) is the group within the FDA that defines the quality requirements for all human drugs under its umbrella (filed as NDAs, ANDAs, BLAs, 351(k)/Biosimilars, and OTC products). The group issued its 2019 Annual Report just this month (read the full report here) that includes a look back […]
The Office of Generic Drugs (OGD) updated its December 2019 (first quarter FY 2020) statistics with metrics, in addition to the approvals, receipts of original ANDAs, and complete response letters that were published a few weeks ago. The OGD reported refusing-to-receive (RTR) four ANDAs, three standard review and one priority review application. While four is […]
Each year at holiday time, we try to provide a little levity in some of our blog posts, as well as spread some good cheer. So here you go – love it or not – we fully expect this to be sung outside Building 31 in Bethesda on the evening of December 24th. To the […]
Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]
August saw the OGD refusing to receive only three applications, one standard application and two priority GDUFA II applications. Quite interestingly, thus far this FY, the number of priority-review applications compared to the number of standard-review ANDAs that have been refused to be received (10/37) is quite high considering that there are many more standard-review […]
