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 […]
April’s unofficial totals for approvals actions were discussed in a previous blog post here, and we mentioned that April showers might bring May flowers. Well, the bloom of approvals so far in May might rival the bloom of flowers that we’re seeing in the California deserts this year! The approval actions posted through May 16th […]
Today, the FDA issued twenty-six new and six revised Product Specific Guidances (PSGs) (here). PSGs provide the Agency’s current thinking on acceptable methods for demonstrating bioequivalence between the Reference Listed Drug or the Reference Standard designated by the Agency (if the RLD is no longer available) and the proposed generic product. These latest PSG additions […]
At the Center for Drug Evaluation & Research (CDER) Small Business Industry Assistance (SBIA) meeting held on April 25th, titled “Facilitating Generic Product Availability Through Product-Specific Guidances (PSGs) for 2024,” the FDA presented some updates regarding the FDA Dissolution Database. Dr. Leah Falade, Senior Pharmacologist in the Office of Pharmaceutical Quality, CDER, was the presenter in Session 6. […]
The FDA recently hosted a webinar focused on the facilitation of generic drug product development through Product Specific Guidances, also known as PSGs. The CDER Small Business & Industry Assistance (SBIA) held a webinar titled Facilitating Generic Product Availability Through Product-Specific Guidances (PSGS) for 2024 on April 25th. The slides and recordings will soon be posted […]
This morning, I was reading an article written by Sally Turner in Pharmaceutical Technology (here), suggesting that the FDA take a greater role in the review and validation of the patents that brand-name companies list in the Orange Book (OB). She addresses the Hatch-Waxman Act’s patent listing provisions and discusses other views held on the […]
