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REGULATORY AND QUALITY AFFAIRS

The Division of Regulatory and Quality Affairs (RQA) is a core service within BARDA that provides strategic opinions on quality and regulatory issues to ensure safe and effective medical countermeasures. RQA supports product development, from contract pre-awarding stage throughout product approval by providing the following services:

  • Collaboration with Product Coordination Teams within BARDA, other Federal Agencies, and product developers to support medical countermeasure programs in each stage of product development and FDA submission. This collaborative effort enables quick and appropriate regulatory solutions to keep with project timelines.

  • Staying up to date with industry practice and FDA guidance to provide all stakeholders with current regulatory and quality advice.

  • Involvement with many cross-functional activities such as source selection, pre/and post-award site visits, quality audits, contract negotiation, production, acquisition, storage, and use. The division ensures product integrity and compliance during the storage life cycle in the National Strategic Stockpile.

  • Providing support to companies in selection of subcontractors, such as laboratories or manufacturing sites and ensuring that quality systems at all contract and subcontract facilities align with FDA regulations.

  • Production and facilitation of documents that enable end users to use products safely via Investigational New Drug (IND) Applications and Emergency Use Authorizations (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.