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Consistent and Appropriate Postmarket Regulation

FY 2008 OCP Performance Report

OCP is required to ensure the consistency and appropriateness of postmarket regulation of combination products. OCP FY 2008 activities and impacts related to the consistency of postmarketing regulation are as follows:

  • Completed preparation of proposed rule on cGMPs for combination products for HHS and final clearance. The proposed rule would clarify and streamline cGMP requirements for combination products. The proposed rule is intended to provide a flexible quality management regulatory framework that recognizes that, in most instances, for combination products, a properly implemented quality systems (QS) program under one set of medical product cGMP regulations will meet the requirements of another set. For example, application of cGMPs for finished pharmaceuticals in 21 CFR 210/211 would generally meet the requirements of the device QS Regulation in 21 CFR 820. This will allow manufacturers the flexibility to select either the cGMPs or QS Regulation to apply for the manufacture of their combination product, provided that their system incorporates select, key provisions from the regulations pertaining to the other part of their combination product. It will avoid the need to fully implement both sets of cGMP regulations when manufacturing combination products. The proposed rule is intended to ensure consistency and appropriateness in the regulation of combination products.
  • Completed preparation of proposed rule on postmarketing safety reporting requirements for combination products for HHS and final clearance. The proposed rule is intended to clarify the postmarket safety reporting requirements for combination products. The proposed rule will provide a framework for the reporting of adverse events for combination products and specify sponsors’ reporting requirements for each type of combination product. Additionally, the proposed rule will clarify the circumstances in which following one set of postmarket safety reporting regulations generally would meet the requirements of another set, and the circumstances in which these requirements would be supplemented with specific reporting provisions applicable to the other constituent part of the combination product. The regulation is intended to ensure the consistency and appropriateness of postmarket safety reporting for combination products while avoiding the need for duplicative reporting requirements.
  • Continued working group activities to consider postmarketing changes to combination products. During the postmarketing period, manufacturers often make a variety of changes to the approved/cleared combination product that may affect its safety and effectiveness. The internal working group is drafting guidance to clarify the regulatory approach for post-approval modifications to an approved combination product and the type of submission to establish the safety and effectiveness of the changes.
  • Undertook a variety of compliance-related and postmarketing activities to help ensure the safety and quality of combination products. These activities included coordinating FDA responses to postmarket safety reports and providing guidance, facilitating, and leading meetings between industry and the Centers on cGMP requirements. Other compliance-related and postmarketing activities included providing support to FDA field inspectors for products seized at ports of U.S. entry to stop illegal products from entering the country; responding to product defect issues; providing guidance on enforcement issues relating to the Prescription Drug Marketing Act and import requirements; and providing warning letter guidance.
  • Convened and chaired a working group on combination product registration and listing. Registration and listing for combination products raises distinct questions relating both to the final combination products themselves and to their device, drug, and biological product constituent parts. Having received a number of inquiries on this topic, OCP convened this working group as a means to facilitate consistent application and implementation of these requirements.
  • Convened and chaired a working group on cGMPs for combination products. As indicated in the discussion above of the proposed rule, application and implementation of cGMPs for combination products raises special challenges. OCP established this working group as a means to consider particularly challenging questions raised by stakeholders and the Centers and to help ensure informed, consistent resolution of identified challenges.
  • Provided clarification and support to Centers and sponsors to ensure consistent and appropriate postmarket regulation of combination products. OCP responded to approximately 40 separate postmarket issues concerning the postmarket regulation of combination products. These issues included the application of cGMPs and QS regulations for inspections of combination products, appropriate mechanisms and manufacturer responsibilities for reporting adverse events, requirements for registration and listing, post-approval changes, import-export issues, labeling revisions, repackaging, off-label use and promotion, postmarket studies, and safety reporting.

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