FDA provides new guidelines to accelerate the development of COVID-19 treatments

pharmafile | May 12, 2020 | News story | Manufacturing and Production COVID-19, FDA, coronavirus, pandemic 

The FDA has provided new guidelines to researchers studying potential COVID-19 treatments to help speed up the process of their development.

They have released new documents that will make the process for submitting applications for initiate studies for new biological products and drugs more efficient. They will also outline recommendations for ways to design clinical trials to evaluate safety and the effectiveness of COVID-19 treatments.

This updated guidance builds on steps the regulatory body has taken to streamline its review and advice program to get clinical studies started as quickly as possible.  The new documents are supplemented by the agency supporting innovative study designs to test multiple products and different populations simultaneously, and get answers on safety and efficacy.

FDA Commissioner Stephen M. Hahn commented on the new guidelines and said: “Our staff continues to work around the clock with the world’s best innovators and researchers to help expedite the development of prevention and treatment options for COVID-19.

“Accelerating the investigation of safe and effective therapies that could benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We are committed to maximizing our regulatory flexibility and using every tool at our disposal to speed the development and availability of these medical products and believe these new guidances will help innovators and researchers do just that.”

During the initial phase of the pandemic, the FDA launched the Coronavirus Treatment Acceleration Program to help get new medical products to patients as soon as possible, if they were shown to be effective and if the potential risks were outweighed by the benefits.

So far there are over 130 clinical trials of potential COVID-19 treatments progressing with FDA oversight.

Conor Kavanagh

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