The US Food and Drug Administration (FDA) has released a draft guidance for sponsors on how the agency determines an applicant has demonstrated good cause in failing to meet postmarketing requirements (PMRs) for human prescription drugs.
Under section 505(o) of the Federal Food, Drug, and Cosmetic (FD&C) Act, applicants with products subject to a PMR are required to update FDA on a drug’s PMR status, such as the current state of a clinical trial or study, and a timetable for the study’s completion. Applicants that fail to provide these updates violate this section of the FD&C Act “unless the applicant has demonstrated good cause for its PMR noncompliance,” which the agency is responsible for determining, FDA said…
