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The new draft guidance “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products” (here) provides the industry with a foundation for providing one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 […]
Today, the FDA published a draft guidance titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Guidance for Industry,” aimed at implementing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 The draft guidance can be found here.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 […]
In an email announcing the two new guidances, the FDA said, “[t]he first guidance titled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices is intended for investigators, industry, and institutional review boards (IRBs). This final guidance provides recommendations to help clinical investigators comply with the safety reporting requirements for investigational new drug application […]
The life-sciences industry has long been synonymous with high barriers to entry. Traditional research and development (R&D) models demand enormous capital investment, specialized infrastructure, and a deep understanding of regulatory compliance. For startups and innovators, these requirements often translate into years of fundraising and risk before a single product reaches the market. However, the emergence […]
The process of debarment began after the generic drug scandal in the late 1980s and the FDA continues to use this process to preclude individuals from participating in a variety of activities, including drug development, manufacture, clinical studies in support of drug applications, and importing drugs into this country if they are have been convicted […]
Even after he originally said that he wasn’t interested in the job, Richard Padzur, M.D., a long-time (26-year!) veteran of the FDA, was named Director of the Center for Drug Evaluation and Research. As the founding director of the FDA’s Oncology Center of Excellence and in his tenure leading the Oncology Division, Dr. Padzur has been […]
As we near the end of October 2025, the first month of new FY 2026, and as FDA appropriations languish in our dysfunctional Congress, the number of fee-paying submissions submitted to FDA so far in the new Fiscal Year 2026 = 0. That’s right nada, nil, zero, zilch, none. You can count the number on […]
ICH Q7 refers to the need to establish the impurity profile for an Active Pharmaceutical Ingredient (API): “An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process should normally be established for each API. The impurity profile should include the identity or some qualitative […]
