Common use of Regulatory Affairs Clause in Contracts

Regulatory Affairs. Development and production of medical products and processes fall under the purview of the Food and Drug Administration (FDA) and research on these products involving animal or human studies is regulated by other laws, directives, and regulations. Project Awards under this Agreement that involve work in support of or related to FDA regulatory approval will address contingencies for Government access to regulatory rights in the event of product development abandonment or failure. Efforts conducted under this OTA shall be done ethically and in accordance with all applicable laws, directives, and regulations. The Government shall ensure performance includes regulatory expertise and guidance for candidate medical countermeasure development efforts: (1) This includes allowing the government to discuss/negotiate in partnership with the consortium how to assume appropriate risk in regulatory strategies. The government will review, negotiate, and come to consensus with the PAH on product-specific risk-based decisions. (2) PAHs will use all regulatory programs to accelerate the pace of candidate medical countermeasure development, including fast-track status, and as appropriate meeting requirements for priority review vouchers, applying for breakthrough therapy and accelerated approval as appropriate (see FDA Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics). (3) PAH will provide FDA submissions to the government such as all documentation requested by FDA and all proposals to FDA. (4) PAH will allow the government to monitor all FDA communications by listening to teleconferences and attending meetings. (5) PAH will allow the government to attend regulatory site visits and audits, and actively participate in all third-party audits. (6) PAH will comply with Quality Assurance according to negotiated standards with the government on reports, material for Interim Fielding Capability (such as Emergency Use Authorization or Expanded Access Protocols), product for trials, prototypes, etc. (7) PAH will provide strategies to address contingencies that could arise from regulatory directives, and regulatory failures.

Regulatory Affairs. ​ Development and production of medical products and processes fall under the purview of the Food and Drug Administration (FDA) and research on these products involving animal or human studies is regulated by other laws, directives, and regulations. Project Awards under this Agreement that involve work in support of or related to FDA regulatory approval will address contingencies for Government access to regulatory rights in the event of product development abandonment or failure. Efforts conducted under this OTA shall be done ethically and in accordance with all applicable laws, directives, and regulations. ​ The Government shall ensure performance includes regulatory expertise and guidance for candidate medical countermeasure development efforts:: ​ (1) This includes allowing the government to discuss/negotiate in partnership with the consortium how to assume appropriate risk in regulatory strategies. The government will review, negotiate, and come to consensus with the PAH on product-specific risk-based decisions. (2) PAHs will use all regulatory programs to accelerate the pace of candidate medical countermeasure development, including fast-track status, and as appropriate meeting requirements for priority review vouchers, applying for breakthrough therapy and accelerated approval as appropriate (see FDA Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics). (3) PAH will provide FDA submissions to the government such as all documentation requested by FDA and all proposals to FDA. (4) PAH will allow the government to monitor all FDA communications by listening to teleconferences and attending meetings. (5) PAH will allow the government to attend regulatory site visits and audits, and actively participate in all third-party audits. (6) PAH will comply with Quality Assurance according to negotiated standards with the government on reports, material for Interim Fielding Capability (such as Emergency Use Authorization or Expanded Access Protocols), product for trials, prototypes, etc. (7) PAH will provide strategies to address contingencies that could arise from regulatory directives, and regulatory failures.. ​