Hyderabad: The US Food and Drug Administration has issued new guidelines which include a recommendation for researchers working for the development of preventions and treatments for novel coronavirus.
According to the guidelines, the researchers will be submitting applications regarding studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials of these medical products for coronavirus.
Stephen M. Hahn, FDA Commissioner says that the staff members continue 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," he said in an FDA press release.
Soon after coronavirus outbreak, the FDA started working with various health partners to advance medical countermeasures against COVID-19.
The Coronavirus Treatment Acceleration Program which was launched by the FDA provided patients with new medical products and at the same time determine its effectiveness.
The FDA has conducted as many as 130 clinical trials of potential coronavirus drugs. The researchers are studying many such therapies related to antiviral drugs to keep viruses from multiplying, as well as therapies called immunomodulators aimed at tamping down the body’s own immune reaction to the virus.
The guidance includes General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products outlining more efficient process for developers to receive agency feedback on their supporting data with the goal of starting clinical trials as soon as possible.
The other guideline deals with Developing Drugs and Biological Products for Treatment or Prevention which provides the FDA’s current recommendations on later-stage clinical trials intended to establish safety and effectiveness for COVID-19 products.
In addition to the FDA’s work to expedite preventative and therapeutic options, the agency had earlier announced that it will work in a public-private partnership with the National Institutes of Health and others to speed the development of COVID-19 vaccine and treatment options.
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