Provision of healthcare is a key topic globally with increasing populations worldwide, increasing healthcare system costs, multiple humanitarian crises, and supply chain concerns. Two weeks ago in Dublin, Medicines for Europe brought together industry leaders and experts to discuss better access to medicines in hopes of addressing at least some these issues. Generic medicines play […]
After two stellar months, the OGD approvals (at least through mid-June) appear to have slowed down a bit, with 31 full-approval actions and six tentative-approval (TA) actions reported through June 16th (here). While there is still time for the approval pace to pick up during the latter part of June, with 37 total approval actions […]
The FDA received no comments on the draft guidance titled Facility Readiness: Goal Date Decisions Under GDUFA, and, as such, has finalized the guidance with only minor editorial changes. The advance prepublication of the Federal Register Notice (here) notes, “[U]nder the commitment letter related to the GDUFA authorization for fiscal years 2018 through 2022 (under […]
Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]
The current state of drug shortages in the supply chain is under continued pressure, both outside of and within the U.S. According to the FDA, there are currently 105 products in shortage in the U.S. (here) as of the drafting of this blog. Not only are the shortages continuing, but adherence to section 506C of the […]
A sneak peek at the Office of Generic Drugs’ May 2024 approval actions should put a smile on the industry’s face as the OGD hit the highest number of total approval actions so far this FY in May. The OGD issued a total of 84 approval actions last month, consisting of 72 full-approval actions and […]
It’s fascinating to see the evolution and potential future of visual inspection in the pharmaceutical industry. The shift from manual methods to cutting-edge automated systems with artificial intelligence has significantly improved efficiency, accuracy, and reliability in product inspections. By leveraging AI technology in visual inspections, pharmaceutical companies can benefit from enhanced defect detection capabilities, greater […]
Well, the numbers look good (as we predicted); however, we missed by a few in our crystal ball calculations. It is possible that at least 2-3 approvals for alternate strengths of previously approved products showed up in the charts, so we were a bit high on the projected full approval numbers (see here) and that […]
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 […]
The Association of Accessible Medicines (AAM) and the BioSimilars Council (a Division of AAM) released a statement of support (here) for a legislative fix to provide a safe harbor for generic / biosimilar label carve-outs. The issue is the potential threat of litigation for inducement to infringe, a problem that could bankrupt a generic or […]
