On Monday, May 11th, the FDA issued two guidance documents regarding the development of products indicated for the treatment and/or prevention of COVID-19. With these documents, the Agency intends to establish a more efficient process for submitting applications to initiate studies for new drugs and biological products, “and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19.”
The first guidance document, entitled COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs and Biological Products, assists Sponsors through the Pre-IND stage by providing them with a more efficient process to obtain the FDA’s feedback on their supporting data for their IND submission. Given that time is of the essence, the goal of this guidance is to help Sponsors get their clinical trials started as quickly as possible.
In addition, this guidance document also provides additional information regarding the types of data and information that Sponsors should provide in order to address clinical, nonclinical, and quality considerations before submitting an IND application.
The major takeaways from this guidance document are as follows:
The second guidance document, entitled COVID-19: Developing Drugs and Biological Products for Treatment or Prevention, focuses on later stage clinical trials that intend to demonstrate safety and effectiveness for products to treat or prevent COVID-19. In a recent statement, FDA notes that the document outlines critical considerations for Sponsors, including “appropriate patient selection, including the evaluation of therapies in patients at high risk of complications from COVID-19 (e.g., the elderly). In addition, the guidance helps Sponsors to understand how to design their trials, including considerations of study duration, assessment of efficacy and monitoring for safety.” The Agency’s goal in issuing this guidance was to assist Sponsors in designing studies as efficiently as possible, hopefully leading to the review and approval of safe and effective drugs and biologics to combat the current global health crisis.
However, it is important to note that in the guidance document, the Agency states that its recommendations do not apply to preventative vaccines and convalescent plasma.
The major takeaways from the second guidance document are as follows:
Right now, the development of drugs and biological products for the treatment and prevention of COVID-19 is the Agency’s top priority. FDA is dedicated to finding a cure for the disease as well as a way to protect the public from future outbreaks by preventing the disease from returning and infecting mass quantities of people. If you are in the process of developing a drug or biologic to treat or prevent the coronavirus, we can help get your product in front of the FDA as quickly and effectively as possible. We have extensive experience helping our clients work their way through the development process, accomplishing each developmental milestone and achieving successful interactions with the FDA along the way.
For more information on our qualifications and capabilities and to learn how we can help you, contact us today.
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