New FDA Draft Guidance on Postmarketing Studies and Clinical Trials

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:

  • will generally be required under the new legislation (postmarketing requirements (PMRs)) and
  • will generally be agreed-upon commitments (postmarketing commitments (PMCs)) because they do not meet the new statutory criteria for required postmarketing studies and clinical trials.

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:

  • Clinical trials: "are any prospective investigations in which the applicant or investigator determines the method of assigning the drug product(s) or other interventions to one or more human subjects."
  • Whereas studies are defined as "are all other investigations, such as investigations with humans that are not 103 clinical trials as defined above (e.g., observational epidemiologic studies), animal studies, 104 and laboratory experiments."
    Previous laws, regulations, and practice have used the terms studies and trials interchangeably.

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For applicants, applicable reports are also described in the draft guidance:

  • PMR Reports
  • PMC Reports
  • Reports for Studies and Clinical Trials Otherwise Undertaken
  • Reports in REMS Assessments (risk evaluation and mitigation strategy)

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.

Compiled by
Wolfgang Schmitt
On behalf  of the European Compliance Academy (ECA)

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