This guidance provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act). This section authorizes the FDA to require certain postmarketing studies and clinical trials for prescription drug and biological products approved under section 505 of the Act or section 351 of the Public Health Service Act (the PHS Act).
The new guidance provides information about the requirements for postmarketing studies and clinical trials under section 505(o) of the Act. The guidance also describes the types of postmarketing studies and clinical trials that:
After giving a brief overview on the past practice, new FDAAA Authority and Requirements are described. Interesting is the new distinction between clinical trials and studies:
The implementation of postmarketing study and clinical trial requirements under FDAAA: When defined conditions are met, the FDA intends than to require the study or clinical trial as a PMR, describing all required postmarketing studies or clinical trials. A PMC has to be used to describe studies and clinical trials that applicants have agreed to conduct, but that will generally not be considered as meeting the statutory purposes and so will not be required.
For applicants, applicable reports are also described in the draft guidance:
The guidance does not apply to non-prescription drugs approved under a new drug application (NDA) or generic drugs approved under section 505(j) of the Act.
The new Draft Guidance can be found here.
On behalf of the European Compliance Academy (ECA)