The COVID-19 epidemic has triggered action from every government agency, including the U.S. Food and Drug Administration (FDA). Charged with, among other things, ensuring the safety and efficacy of drugs and medical devices, the FDA has taken steps to both accelerate the biotech and life sciences industry’s work to test, diagnose and treat COVID-19 as well as rein in misguided or unscrupulous COVID-19 products.

The FDA created the coronavirus treatment acceleration program (CTAP) to expedite the development of COVID-19 therapies. CTAP attempts to streamline the process for developing potential COVID-19 therapies by creating teams of clinical reviewers and regulatory experts to quickly review COVID-19 therapeutic proposals and route them to the correct unit within the FDA, advise less experienced parties making such proposals, move mature proposals through the pre-investigational new dug (Pre-IND) meetings to obtain initial advice and then move into clinical trials.

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