FDA published a revised draft guidance titled Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry. If you have any post approval study requirements for any of your products, you should pay close attention to this document.
In describing the document, the Agency says:
“This guidance describes FDA’s statutory authority to require certain postmarketing studies and clinical trials under section 505(o)(3) of the FD&C Act (i.e., postmarketing requirements (PMRs)) and provides an overview of the types and purposes of such studies and clinical trials. This guidance also describes those types of postmarketing studies and clinical trials that are agreed upon (i.e., postmarketing commitments (PMCs)) between FDA and the applicant.”
This is a revision of a 2011 draft guidance of the same name. The current document “also reflects certain provisions enacted under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act as they relate to postmarketing studies and clinical trials.” The draft guidance notes that the Agency does not differentiate between active ingredients that are controlled substances or non-controlled substance prescription products. It also does not cover OTC products that are the subject of an approved application or products approved as generics under an ANDA.
After approval of certain drug applications, the FDA may require post marketing studies or clinical trials. Under section 505(o)(3) of the FD&C Act, applicants are required to report on the status of these studies and trials annually. The reports are to include:
- A timetable for completion
- Periodic reports on the status of the study, including whether any difficulties in completing the study have been encountered
- Periodic reports on the status of the clinical trial
The draft guidance also describes whether the information submitted to the Agency will be sufficient, as well as other important considerations. The full draft guidance can be found here.