On October 26, 2020, a business plan was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) that eventually resulted in a holistic revision to ICH Q9, “Quality Risk Management,” the “R1” of the framework. The four areas of concern were identified as: High levels of subjectivity in risk assessments […]
As we approach the last week in March, we now have one-third of FY 2025 behind us. January’s ANDA approval numbers continue to look good, as we discussed in our February 6, 2025 post on the unofficial January approval actions (here). Another month with 90 total approval actions is good news for industry. The monthly total is […]
In a pre-publication notice in the Federal Register today (here), the decision on the issuance of the rule will be kicked down the road another sixty days until May 21, 2025 so the FDA/administration can fully vet the rule. This is the second delay since it was published as “a final rule, titled ‘Nonprescription Drug Product […]
The over-the-counter monograph drug facility (OTC MDF) fees for FY 2025 are effective on October 1, 2024, and fees will be due on June 2, 2025. There are two types of facility fees for OTC drug manufacturing facilities: An OTC MDF is a foreign or domestic business or other entity that, in addition to meeting other criteria, is […]
In today’s rapidly evolving technological landscape, pharma and biotech businesses are increasingly looking to leverage artificial intelligence (AI) to gain a competitive edge. However, before diving headfirst into AI, it is crucial to lay a solid foundation. One of the most effective ways to do this is by implementing a Unified Namespace (UNS). This blog […]
On March 11, 2025, the EU formally proposed a regulation to not only fight drug shortages but also to maintain its status as a global leader in the production of pharmaceutical products. We have previously published a blog that identified the convergence of U.S. and EU efforts that can be found here. While the U.S. navigates […]
The old saying “March comes in like a lion and goes out like a lamb” might apply to March 2025 as the OGD has issued 34 full-approval actions and 17 tentative-approval actions through March 17th. The biggest day was the first business day of March when the OGD pushed out eleven full- and four tentative-approval […]
Last week, I had the privilege of attending The Indian Pharmaceutical Alliance’s 10th Global Pharmaceutical Quality Summit in Mumbai. Not only was the event loaded with excellent content presented by leaders of the generics industry, it also provided invaluable chances to discuss innovation and opportunities for the industry with individuals in quality from around the […]
After a March 6, 2025 report from an independent testing facility claimed that a significant number of acne products containing benzoyl peroxide were found to have very high levels of benzene (here), the threat has been countered by the FDA’s own testing of 95 products. After the FDA’s testing results were confirmed, it announced that the “FDA […]
Since 1976, the International GMP Conference has been co-sponsored by the University of Georgia College of Pharmacy and the U.S. Food & Drug Administration. However, this year, through no fault of the Agency, the FDA was unable to attend. This was unfortunate (to say the least), especially as this public-private collaboration amongst a number of […]
