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 […]
Because we know that information regarding approval actions of original ANDAs is critical to the industry, we track them as closely as we possibly can in order to give the readers the latest information. The full approval and tentative approval actions are the lifeblood of the industry. February 2020 continues on the lower end, and […]
Well, here we are in 2020, almost halfway through GDUFA II, and what do we know? We know that the OGD expects approvals to slow down, but original ANDAs to begin to fill up the system again. We have already seen the slowdown in approvals and, according to the OGD, this is likely to continue […]
Well, I am back from three weeks of traipsing around South America and ready to hit the blogging trail again. Thanks to all my Lachman colleagues who took up the charge and did a great job in my absence. However, while away, I tried to keep up by reading the trade press when I had […]
The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here). A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]
The use of contract manufacturers for the production of approved drug products has become more and more commonplace, particularly with the steady increase through the years of virtual pharmaceutical companies, a business model where the majority of the drug development and production work is outsourced to third parties as needed. While the use of a […]
The official OGD stats are out for approval and tentative approval actions, as well as complete response letters issued and receipts of original ANDAs. In January 2020, OGD issued 49 full approval actions, the lowest by far for FY 2020. Of those 49, only one was cited as a first-time approval (I think this might […]
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 […]
As of February 4, 2020, there have been 49 full approval actions and 13 tentative approval actions posted for January 2020. As always noted, these number come from the available data on FDA’s All Approvals site (here) and FDA’s Recent New and Generic Drug Approvals list which is updated daily (here). The official numbers will […]
