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 consistency, improved resource utilization, and streamlined quality control processes.  While the advantages of AI-driven visual inspection are clear, it is ess ..read more

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 is why we call them unofficial. Anyway, the official numbers that are most important to the industry for April are the approval actions which were 65 full approval (highest month this fiscal year, thus far) and 12 tentative approvals, for a total of 77 approval actions. Of the 65 appro ..read more

A May 28, 2024 review article by Skylar Jeremias titled, “New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching” (here), supports the fact that switching between biologics and biosimilars or from one biosimilar to another does not present a problem. The article states “[S]ince the July 2022 publication of the first systematic review of biosimilar-to-biosimilar switching, the European Medicines Agency and the European Heads of Medicines Agencies have issued statements supporting the safety and efficacy of such switching. The U.S. FDA’s systematic review and meta-analysis also found no s ..read more

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 will be covered today and that reference was only a month ago, in late April (here). Today’s blog will focus on the IRA; this is not a discussion on Individual Retirement Accounts but rather the Inflation Reduction Act and the impact of this law on generic dr ..read more

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 biosimilar company just for saying their product is the “generic of” or the “generic equivalent of” or is bioequivalent to the brand name product. The AAM letter (at the link above) explains in detail the problem and “supports the statutory safe harbor for c ..read more

The current FDA Drug Shortage List (here) identifies 110 drugs in shortage.  Please note that the list contains 128 entries, but 18 of the drugs on the list are reported with their shortage status as resolved.  In contrast, the American Society of Health-System Pharmacists (ASHP) lists 254 products on its drug shortage list (here).  Apparently, the discrepancy is a result of different reporting modes and different data-capture mechanisms. In April 2024, we published a blog (here) outlining some of the issues surrounding the complexity of solving the drug shortage problem.  ..read more

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 are forty-one full approvals and four tentative approvals.  If the rate of approvals comes close to what we have already seen in the first half of the month, we are likely to have the first month with over eighty approval actions this fiscal year.  Our u ..read more

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 cover a wide variety of dosage forms and products.  If you have any products on the list in development, be certain to evaluate your development program to either incorporate the FDA-recommended bioequivalenc ..read more

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.  This presentation, along with other presentations on hot topics that were discussed during the webinar, will be posted on the FDA CDER website soon.  Look for the po ..read more

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 on the FDA’s website (keep your eyes open for the posting); they are worth the listen if you didn’t have a chance to listen live.  The webinar provided an overview of the PSG program, provided som ..read more