The FDA revised its 2015 draft guidance on developing drugs to treat idiopathic and diabetic gastroparesis. The revisions reflect the agency's current thinking on the development of clinical outcome assessment measures, as well as the statistical considerations for using those measures to assess primary and secondary efficacy endpoints. Given the unmet need for chronic therapies in the space, the FDA said it intends the revisions to provide a path forward for drug development for gastroparesis. Comments on the revised draft are due by Oct. 13.
The FDA finalized its guidance "Child-resistant packaging statements in drug product labeling." The guidance discusses what information should be included to support child-resistant packaging statements for both prescription and over-the-counter drugs. The goal is to help ensure that the labeling is clear, useful, informative and, as much as possible, consistent in content and format.
The FDA finalized its 2016 guidance discussing the nonclinical evaluation of drugs intended to treat osteoporosis. The guidance provides recommendations on the design of bone quality studies in appropriate animal models that are needed to support the approval of osteoporosis drugs and biologics. It also discusses bone-specific pharmacologic and toxicologic endpoints to evaluate the effects of a drug on bone quality in the nonclinical testing. The final guidance modifies the recommended number of dose levels to be evaluated in the bone quality studies and adds a recommendation to use a multifactorial approach to determine the treatment duration in the studies, according to a notice in Federal Register.