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U.S. Department of Health and Human Services

Division of Regulatory & Quality Affairs

The successful lifecycle management of medical countermeasures (MCMs) spans development, production, acquisition, storage, and use. By working with regulatory agencies like the Food and Drug Administration (FDA) and BARDA’s partners in industry and academia, the Division of Regulatory and Quality Affairs (RQA) helps to minimize inherent risks within the regulatory review and approval process for medical countermeasures. RQA develops strategies to facilitate the regulatory development pathway and to anticipate product lifecycle issues. It applies quality and regulatory best practices to the life cycle management of MCMs ultimately needed for stockpiling, delivery, and use.

Improving MCM Readiness to Protect the Nation

RQA works with BARDA staff, the FDA, and product developers to find regulatory solutions that improve access to numerous MCMs that might be needed during a public health emergency such as the event of an attack or threat, manmade accident, or emerging infectious disease.

RQA makes recommendations for the best regulatory mechanism needed for new or unapproved MCMs that may be need to protect the public health from a variety of threats or attacks. The division conducts detailed reviews for many BARDA-sponsored programs developing MCMs. For example, the RQA may provide support and recommendations for Investigational New Drug applications (IND) needed for a new medical countermeasure for an emerging disease or pandemic outbreak. In other cases, the RQA may facilitate or provide guidance for alternate regulatory approval mechanisms such as the Emergency Use Authorization for unapproved MCMs needed in a declared public health emergency. The RQA’s role helps ensure the availability and delivery of safe, effective, and quality MCMs needed in a time of a public health emergency.

Providing Regulatory Guidance and Support for ASPR and BARDA

RQA provides regulatory and quality support, advice and guidance to BARDA and ASPR program staff reviewing and managing MCM product development.

At the beginning of the product development lifecycle, RQA reviews and develops regulatory and quality strategies to assist with source selection, contract negotiation, and contract life cycle issues involved with development and/or acquisition of MCMs. Once the contract has been awarded, RQA monitors key regulatory and quality performance measures; performs quality audits; and provides regulatory opinions on specific issues. RQA ensures that BARDA staff are kept up to date on regulatory and quality issues and educates them on various regulatory and quality issues. RQA also provides regulatory guidance for the storage, maintenance and use of MCMs.

Helping Partners in Industry and Academia Navigate the Regulatory Process

In order to develop a MCM and bring it to licensure, every product must go through a strict regulatory process so that we can be sure the products are safe and effective. BARDA, ASPR, and other federal agencies support numerous MCM programs in various stages of regulatory review and approval.

RQA helps BARDA’s program staff and their partners in industry and academia better prepare for regulatory reviews and create strategies to comply with federal regulatory requirements. RQA reviews FDA submissions, educates BARDA partners on regulatory or quality affairs topics, and can help prepare for or attend FDA meetings to help facilitate progress. In addition, RQA facilitates the development and availability of medical countermeasures by working collaboratively with partners in industry and academia and our interagency regulatory partners, such as the FDA and CDC, throughout the MCM development process. By facilitating effective communication regularly, thoroughly and accurately, RQA protects federal investments in BARDA-sponsored MCMs and minimizes risks inherent in the regulatory process.

  • This page last reviewed: July 27, 2016