The US Food and Drug Administration (USFDA) Center for Drug Evaluation and Research recently released updated guidelines "Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment" and "Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies" whereas the Center for Biologics Evaluation and Research released "Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy".
Pediatric Inflammatory Bowel Disease (IBD) is a chronic, immune-mediated disorder characterized by relapsing and remitting intestinal inflammation. Pediatric UC is a type of pediatric IBD that is predominantly restricted to the mucosa of the large intestine.
According to the FDA's draft guidance, clinical studies for the treatment of pediatric ulcerative colitis or pediatric Crohn's disease must include the following attributes, such as the study population, the study design, efficacy considerations, and safety assessments.
A human radiolabeled (most commonly 14C or 3H) mass balance study is the single most direct method to obtain quantitative and comprehensive information on the absorption, distribution, metabolism, and excretion (ADME) of the drug in the human body.
This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs, including:
deciding whether and when to conduct the study,
designing the study, and
reporting results.
This guidance does not cover animal mass balance studies, safety testing of drug metabolites, or recommendations for selecting the radioactive dose.
The purpose of this guidance is to inform establishments that collect blood and blood components (blood establishments) for transfusion or further manufacturing purposes (including Source Plasma) of the regulatory requirements for determining donor eligibility. The revised requirements were implemented in order to assure the safety of the blood supply and to protect donor health.
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