With the development of new technologies and drugs, the need for certain products to be presented as combination products for administration is becoming more and more commonplace. According to the FDA FAQs page on Combination Products (here), “Combination products are typically marketed under a marketing authorization type associated with the constituent part that provides the […]
On June 6, 2024, the FDA warned patients and healthcare professionals of the potential danger of sulfites in compounded medications. Remember that prescription products that contain sulfites are required by law to contain a sulfite warning due to the potential for serious adverse events in patients who have sulfite allergies. The warning (here) notes that the […]
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 […]
Forget the cadence of the traditional three-to-five-year business plan when it comes to Artificial Intelligence (AI). The pace of change in this environment has indicators that need to be followed on a quarter-by-quarter basis. In Q1, we wrote about the fast evolving environment both from the legal perspective and the regulatory aspect in blogs that […]
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 […]
Well, we hit the nail on the head (at least for approval actions in March)! As predicted in our April 5th post (here), OGD issued 48 full approval actions and 13 tentative approval actions for a (low) total of 61 approval actions, and that is exactly what OGD is reporting in its official monthly stats […]
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 […]
Join us at this year’s conference for a great exchange of ideas, and the celebration of FDLI’s 75th Anniversary! Lachman Consultants is excited to be part of the upcoming 2024 Food and Drug Law Institute (FDLI) Annual Conference, scheduled for May 15-16 in Washington, DC. The conference serves as an invaluable platform for professionals across […]
Well, it must be true that April showers bring May flowers. A shower of approvals in April is something we haven’t seen in a while. The OGD unofficially issued sixty-eight full-approval actions and eleven tentative-approval actions for a total of seventy-nine for the month. We still must wait for the official numbers to be posted, […]
