Drugs

2 Final Post-Approval Activity Guidances

FDA has published two final guidances it says are intended to enhance patient safety by facilitating timely initiation of post-approval studies (PAS) and postmarket surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act. “The guidances are also intended to increase transparency to stakeholders on FDA’s approach to the issuance and tracking of 522 orders and PAS requirements,” FDA says in a statement.

The first guidance, Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order, is intended to assist stakeholders with understanding PAS requirements imposed as a condition of premarket approval application (PMA) approval. The document provides procedural information; recommendations on the format, content, and review of PAS-related submissions; recommendations to help facilitate FDA’s review of a PAS protocol on time; recommendations for study timelines, including enrollment milestones and study completion; revised definitions of PAS status categories that the agency believes better reflect the progress of a PAS; and revised FDA review time goals for PAS-related submissions.

The second guidance, Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, is to assist manufacturers of medical devices subject to Section 522 postmarket surveillance orders. The document provides an overview of Section 522; information on how to fulfill Section 522 obligations; recommendations on the format, content, and review of postmarket surveillance plan and report submissions, including revised FDA review times for postmarket surveillance-related submissions; and updated surveillance status categories to better reflect progress.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome