New MAPP details when FDA notifies drugmakers about ARIA studies

Regulatory NewsRegulatory News | 17 August 2020 |  By 

In a new manual of policies and procedures (MAPP) released on Monday, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) explains how and when it will notify applicants when the agency plans to study a product using its Sentinel active risk identification and analysis (ARIA) system.
Before FDA can require a postmarketing study or clinical trial for a drug, it must determine whether its ARIA system or adverse event reporting systems would be sufficient to answer the question of interest. In the newly released MAPP, FDA lays out how it will notify applicants when it determines that a study using ARIA would be sufficient to assess a potential serious risk.
FDA explains that CDER’s Office of New Drugs (OND) will notify applicants when it and the Office of Surveillance and Epidemiology (OSE) plan to initiate a study using Sentinel ARIA in an approval letter and during the late cycle meeting for the application.
OSE is also tasked with notifying applicants when study parameters are finalized, at least two business days before posting the analytic package or study protocol to the Sentinel Initiative website. FDA says that OSE intends to notify applicants at least two business days before the first public release of study results, except when the release is part of an advisory committee package or will appear in a peer-reviewed publication.
Additionally, FDA says that OSE “intends to send the study results to applicants when the study results inform a regulatory action, such as a safety-related labeling change.”
However, FDA says that it may not notify an applicant prior to the release of Sentinel ARIA results when an urgent safety communication is necessary. “In these situations, which may involve adverse events that are emergent threats to public health that require immediate action to mitigate or prevent harm, timeliness and transparency to the public are paramount.”
FDA notes that it will not notify applicants whose products are used as comparators in Sentinel ARIA assessments unless those products are also under evaluation and that it will not notify applicants when conducting Level 1 descriptive ARIA analyses as part of routine pharmacovigilance activities.
The MAPP includes two tables detailing the agency’s applicant notification process in the preapproval and postmarket phase and provides details on the responsibilities and internal procedures for communicating with applicants regarding ARIA assessments and results.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy