I had the good fortune to attend the FDLI Annual Meeting held on May 6th and 7th. The FDLI Annual Meeting is always a good conference where attendees are able to hear many great updates from the FDA and insights on issues related to our industry. This year was no exception, and the FDA had a […]
Just one too much controversies, just too many career FDAers’ decisions overridden, just too much change to vaccine recommendations, and, apparently, just one too many changes in previously agreed-upon requirements have led to the second departure of Vinay Prasad from the position of Director, Center for Biologics Evaluation and Research. Commissioner Makary announced that Prasad […]
The newly named Board Chair of the Association of Accessible Medicines (AAM), Bob Hoffman, Chief Commercial Officer of U.S. Generics for Lupin Pharmaceuticals, provided his view of the current state of the generic and biosimilar industry and some of the issues he is concerned about. Bob noted that the “current system need a course correction” […]
The Association of Accessible Medicines (AAM) continued Day 1 with a discussion of what’s happening on Capitol Hill and how we can be working to position industry priorities with policymakers to make the most positive impact on patient access. The session was conducted as a fireside chat hosted by Mark Ratner, Senior Vice President, Government Affairs, […]
John Murphy III, CEO of the Association of Accessible Medicines (AAM), opened the conference by welcoming the participants and providing an interesting walk through the current environment and how the AAM hopes to navigate the current political environment to make drug products, both generic and biosimilars, more accessible and affordable. He noted that “affordable medicines […]
Lachman Consultant Services, Inc. is pleased to announce its participation in PDA Week 2026, the premier annual homecoming event for the global pharmaceutical community. This flagship industry gathering will take place March 22–27, 2026, at the Gaylord Rockies Resort & Convention Center in Denver, Colorado. PDA Week brings together scientists, quality experts, regulatory leaders, and […]
The FDA issued a guidance document “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” (September 2025) (here) that focusses on the analytical approaches to be employed for comparative testing to demonstrate similarity between the proposed recombinant protein product and the reference (recognizing that the tools within the guidance could be applied […]
The International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) endorsed a new draft guidance on extractables and leachables in August 2025 that the FDA has since published for review and comment. The version published by the FDA is accessible at Q3E Guideline for Extractables and Leachables and includes Supporting Documentation: […]
Why Using Full-Scale Deflection Introduces Data Integrity Risks In pharmaceutical manufacturing, Accuracy is a critical ALCOA+ principle that can sometimes get lost, particularly when assessing the holistic system. The field instrument level needs to be adequately integrated into the overall assessment, especially in aseptic manufacturing environments where sterilization is critical (and accurate data, such as […]
The newly issued revised and finalized “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry” (here) does not differ much from the previous draft guidance of the same title issued on April 25, 2024 (89 FR 31757). The final guidance was revised to incorporate comments […]
