Overview
The U.S. Food and Drug Administration has produced a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.
“Accelerating the investigation of products that could potentially benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities.”
FDA Commissioner Stephen M. Hahn.
FDA RAPID Protocol review
The FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly.
The FDA has reviewed study protocols as fast as within 24 hours and in many cases has reviewed single-patient expanded access requests within three hours.
The FDA is also collaborating with federal partners, developers and researchers to create protocols that can be used across institutions and programs to streamline efforts.
FDA Product Inquiries:
Requests for product development for proposed COVID-19 uses and drug development should be sent to covid19-productdevelopment@fda.hhs.gov
Global Regulatory Partners is Supporting the Fight Against Coronavirus (COVID-19) Contact us to learn more.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.