FDA’s Coronavirus Treatment Acceleration Program

by | Apr 3, 2020 | Coronavirus, FDA, Medical Devices, Pharma, Quality Systems, Requirements

On Tuesday, March 31, 2020, the FDA announced a new program aimed at facilitating research and development of COVID-19 treatments. With over 920,000 confirmed cases globally, the Coronavirus pandemic is forcing the FDA to create a rapid pathway for treatments.1 The new Coronavirus Treatment Acceleration Program (CTAP) is the FDA’s answer to the massive surge of inquiries across the public, academic, and private sectors looking for ways to treat COVID-19. With this program, the agency hopes to bring new therapies to patients as quickly and safely as possible.

Under the CTAP, staff from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) will be providing feedback and interactive input to inquiries as quickly as possible. The Agency’s goal is to respond to developers within a day, conduct trial protocol reviews within 24 hours, and review single-patient expanded access requests within 3 hours.2 To keep up with these goals, and the influx of firms trying to get their COVID-19 treatments to patients, the FDA is working around the clock and redeploying medical, regulatory, and operations staff to serve on review teams solely dedicated to COVID-19 therapies.

While the FDA is trying to maximize its regulatory flexibility, they are also still prioritizing patient safety. The FDA is prioritizing well-controlled trials to reliably determine that a COVID-19 therapy can safely and effectively treat patients.3 The agency is also working with drug-makers and researchers to develop study protocols that can be universally implemented in order to streamline efforts while still maintaining safety.

According to the FDA, there are 10 therapies in active clinical trials, and another 15 in planning stages; with the CTAP now live, they are hoping to see those numbers grow. If you have a potential COVID-19 therapy and need help navigating the FDA pathways, EMMA International can assist. We are keeping up to date with all the regulatory responses to the pandemic and are ready to help. Give us a call at 248-987-4497 or email info@emmainternational.com for more info!

1WHO (March 2020) COVID-19 Situation Report -71 retrieved on 03/31/2020 from: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200331-sitrep-71-covid-19.pdf?sfvrsn=4360e92b_4

2Mehzer, RAPS (March 2020) New FDA Program to Accelerate Coronavirus Treatments retrieved on 03/31/2020 from: https://www.raps.org/news-and-articles/news-articles/2020/3/new-fda-program-to-accelerate-coronavirus-treatmen?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2031%20March%202020

3FDA (March 2020) COVID-19 Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19 retrieved on 03/31/2020 from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-accelerate-development-novel-therapies-covid-19

Madison Green

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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