The pharmaceutical supply chain is no longer just a chain of physical materials, but rather a complex series of data, data-based decisions, and delegated responsibilities for that data. FDA’s CDER FY2024 Site Catalog reported 4,619 manufacturing sites globally, reflecting the broad scale of the regulated manufacturing network supporting the U.S. drug supply. Within that network, […]
The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]
The new draft guidance “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products” (here) provides the industry with a foundation for providing one adequate and well-controlled study with appropriate confirmatory supporting data to satisfy the Agency’s requirement for demonstrating safety and efficacy. While this may, on its face, appear to be a boon […]
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 […]
Yesterday, the FDA announced that the modification made to the iPLEDGE Program Risk Evaluation and Mitigation Strategy (REMS), previously announced in November 2023 and approved on March 8, 2026, has been pushed back until November 15, 2026 “to allow additional time to test iPLEDGE REMS system updates, minimize technical issues for users of the iPLEDGE REMS platform, […]
Today, the FDA published a draft guidance titled Forms FDA 3542a and FDA 3542: Questions and Answers (here) that provides NDA sponsors with more information on patent submission than perhaps you ever even thought possible. The document identifies twenty-nine different questions and corresponding answers to clarify who needs to submit patent information, what patent information […]
In the Federal Register of March 3, 2026, the FDA published a request for information and comments on the Agency’s series of guidances for industry on Scale-Up and Post-Approval Changes (SUPAC) for specific dosage forms. Based on the requests received from interested parties, the FDA is reopening the comment period and extending it for an additional […]
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 […]
