Initial Inquiries to the FDA for COVID-19 Products
The FDA recently launched a new program known as the Coronavirus Treatment Acceleration Program (CTAP) to expedite the development of potentially safe and effective life-saving treatments for COVID-19. CTAP aims to use every tool at the Agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate the efficacy and safety of the products.
Prioritization of interactions: The review teams prioritize Sponsor interactions based on the product’s scientific merits, stage of development, and identification as a possible priority product. According to the FDA, “Because the overriding objective is to develop safe and effective treatments for American patients as soon as possible, the strongest proposals will go to the front of the line on the basis of scientific merit.”
Camargo is actively supporting clients as they navigate the development of COVID-related therapeutic products through both the pre-IND and the pre-EUA pathways. Based on our extensive expertise, we can help move your development program forward by the quickest route available.
above taken from Camargo website.
So if our formula can be seen as highly effective, it can go to the front line and expedite the whole process. May happen sooner than many originally thought possible - myself included.
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