The U.S. Food & Drug Administration (FDA) issued a guidance on providing regulatory submissions in electronic and non-electronic format. This guidance pertains to submissions of promotional materials for human prescription drugs to the FDA made by manufacturers, packers, and distributors, whether the applicant or an entity acting on behalf of the applicant. Specifically, this guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER). This guidance also explains certain aspects of electronic submission of promotional materials in module 1 of the electronic common technical document (eCTD).
FDA announced the availability of a new guidance entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” This guidance clarifies that certain provisions of the 2018 Requirements related to informed consent are not inconsistent with FDA’s current policies and guidances. The guidance also reminds stakeholders that FDA’s current regulations for expedited review and continuing review must be followed for FDA-regulated studies.
The revisions to the Department of Health and Human Services’ (HHS’) Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule” or “2018 Requirements”) have created certain differences between FDA’s human subject regulations and HHS’ human subject regulations. While FDA intends to undertake rulemaking to harmonize, to the extent practicable and consistent with other statutory provisions, its regulations with the 2018 Requirements consistent with Section 3023 of the 21st Century Cures Act, we recognize the potential for confusion in the interim for sponsors, investigators, and IRBs who are involved in both HHS-regulated research and FDA-regulated clinical investigations. This guidance is intended to clarify the impact of certain provisions of the 2018 Requirements on FDA-regulated clinical investigations.
The guidance is available to download on FDA’s website
Today the FDA issued both the final rule on “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices” and the guidance document “FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.” The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted both inside and outside the United States to help ensure the protection of human participants, and to help ensure the quality and integrity of data obtained from these clinical investigations.
The final rule amends FDA regulations on acceptance of data from clinical investigations conducted outside the United States to reflect the increasing globalization of clinical trials and the evolution of clinical trial standards for protecting human subjects. The new rule requires that sponsors and applicants provide statements and information about how the investigations conform with good clinical practices (GCP). This applies to clinical data submitted to support investigational device exemptions (IDE), premarket notifications (510(k)), requests for De Novo classification, premarket approvals (PMA), product development protocols (PDP), and humanitarian device exemptions (HDE). The FDA believes that the requirements set out in the final rule provide flexibility for medical device sponsors conducting multinational clinical trials by allowing them to describe the standard for good clinical practice they followed.
The final rule also amends the IDE, 510(k) and HDE regulations for FDA acceptance of data from clinical investigations conducted within the United States to require a statement regarding compliance with FDA regulations for human subject protection, institutional review boards, and IDEs. This change is intended to provide consistency across different submission or application types.
The guidance document “FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions ” is in question and answer format and provides clarifications and recommendations to help stakeholders ensure that studies conducted in the U.S. or foreign countries comply with the new rule and revised regulations.