Over the last six to eight months, the FDA’s activity regarding compliance with the required posting of ongoing and completed clinical trials has significantly increased, as evidenced by the issuance of multiple warning letters and letters of non-compliance to sponsors and/or principal investigators. To assist responsible parties in complying with the requirement to post on […]
On June 2, 2026 in The Wall Street Journal, Charles L. Hooper and David R. Henderson wrote “…Remove efficacy from the FDA’s approval process and focus on safety alone. That would improve doctors’ ability to match patients with the best drugs and help Americans live longer, healthier lives. Medicine is a matchmaking exercise in which potentially beneficial drugs […]
Today, the FDA published a draft guidance titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Guidance for Industry,” aimed at implementing streamlined approaches for nonclinical safety assessments of certain oncology pharmaceuticals. The draft guidance can be found here. The document provides some interesting background on the evolution of the Agency’s thinking […]
A Federal Register (FR) notice that appeared on today’s pre-publication page discusses a request for comments on a draft nondisclosure agreement (NDA) for federal employees. The notice (here) discusses the proposed NDA to affirm “[f]ederal employees’ acknowledgment of, and agreement to comply with, current legal obligations to safeguard non-public, confidential, or proprietary information, created or […]
I had the privilege of attending the TIDES conference in Boston from May 12th to 14th. TIDES is always a standout event where attendees can hear about the latest advances in oligonucleotide and peptide therapeutics, along with valuable insights into the evolving landscape of drug development and manufacturing. This year was no exception, with a strong […]
While endotoxin and pyrogen testing might not be the sexiest of topics, they are extremely important topics for creating a safe sterile product. I believe that FDA has made your job easier by their recent publication of the guidance titled Pyrogen and Endotoxins Testing ‒ Questions and Answers (Edition 2) yesterday (here). It contains 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 […]
Ever since the FDA issued a Refuse-To-File (RTF) letter to Moderna regarding its initial determination not to review the Biologics License Application (BLA) for Moderna’s new mRNA flu vaccine, the buzz in the industry has sounded as loud as a chainsaw cutting through the thick trunk of a giant redwood tree. How could this happen? […]
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 […]
