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REGULATORY AND QUALITY AFFAIRS

In order to develop and move a medical countermeasure through FDA licensure/approval/clearance (referred generically from here on as FDA approval), the product development must include considerations for patient safety and the appropriate regulatory pathway to ensure products are effective. The Division of Regulatory and Quality Affairs (RQA) is a core service within BARDA which provides strategic opinions on specific quality and regulatory issues.

As part of a multi-disciplined approach, RQA collaborates with Product Coordination Teams within BARDA, other Federal Agencies, and product developers in support of numerous medical countermeasure programs in various stages of regulatory review and approval. The collaboration with internal and external resources enables quick and appropriate regulatory solutions that keep with project timelines. On a continual basis, RQA stays informed on standard industry practices and regularly communicates to contractors and internal teams on various regulatory and quality issues.

The successful lifecycle management of a medical countermeasure spans development, production, acquisition, storage, and use. RQA is involved with many cross-functional activities of development and/or acquisition of medical countermeasures such as source selection, pre-award site visits, and contract negotiation. RQA is instrumental in the pre-award site visit to assess the feasibility of a medical countermeasure development and production at the site.

Once the contract has been awarded, RQA monitors key regulatory milestones. RQA assists in developing regulatory strategies in accordance with FDA guidances to facilitate the regulatory development pathway and to anticipate product lifecycle issues. Additionally, RQA maximizes its relationship with FDA, industry and academia partners to minimize inherent risks to ideally avoid lengthy delays within the regulatory review and approval process.

RQA provides support to companies that may not have extensive knowledge in selection of a contract laboratory or manufacturing site and ensures a contract facility's quality systems align with FDA regulations. The division may conduct quality audits of primary contractors, observe subcontractor audits as well as provide guidance on storage, maintenance and use of medical countermeasures. The division applies regulatory and quality best practices related to the medical countermeasure product lifecycle to ensure product integrity and compliance during long-term storage in the Strategic National Stockpile.

Within the various project teams, RQA provides regulatory advice and guidance to BARDA program staff reviewing and managing medical countermeasure product development. The RQA division conducts detailed reviews for many BARDA-sponsored programs developing medical countermeasures. Early in the product development lifecycle, RQA provides guidance to assist with developing regulatory strategies. RQA makes recommendations for the best regulatory mechanism needed for new or unapproved medical countermeasures that may be need to protect the public health from a variety of threats or attacks.

RQA also provides traditional regulatory support such as submission of Investigational New Drug (IND) applications to FDA. In addition, the RQA may sponsor, facilitate and/or provide guidance with regard to Emergency Use Authorization (EUA) for unapproved medical countermeasures or an unapproved use of an approved medical countermeasure needed in a declared public health emergency.

Click here for a list of relevant guidances for FDA regulatory review