COVID-19

Edited 04/16/2020 - Coronavirus Disease 2019 (COVID-19)

Facet has direct experience working with the FDA in relation to the development of COVID-19 therapeutics. Based on our experience and the information publicly available from FDA, we are providing the following guidance and recommendations.

FDA has issued a new guidance document that may be applicable to you:

Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers

FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the COVID-19 public health emergency.  In a Q & A format, it addresses numerous direct and indirect ways FDA activities have been affected by COVID-19.  It also indicates that, by in large, FDA is continuing to hold formal meetings (via teleconference), and adhere to stated application review timelines.  See the guidance and/or ask Facet how your non-COVID-19 development program may be affected.

THINGS YOU NEED TO KNOW IF YOU:

Currently market or distribute a biologic (vaccine, human tissue and blood product), medicine, medical device or diagnostic test

 

Use a product in the clinic conducting investigations under an IND
Want to develop your product for diagnostic or therapeutic use in COVID-19 patients

 

  • FDA has set different standards for diagnostics and therapeutics

 

 

  • There are currently no FDA-approved vaccines for COVID-19, but several companies are working to develop vaccine candidates. See clinicaltrials.gov for details.

 

 

  • At the present time, FDA is requiring controlled clinical trials to evaluate investigational drugs and biologics for the treatment of COVID-19.

 

  • Unless your product is an antiviral, it is not enough to have a hypothesis that your drug/biologic will work in COVID-19 patients. FDA is likely to require relevant in vitro or in vivo data in models of coronavirus (e.g., SARS) to support an IND application for your investigational product for COVID-19.

 

  • FDA is not currently granting expanded access (compassionate use) to unapproved non-antiviral therapeutics for COVID-19. The most appropriate way to approach the Agency with your potential therapeutic is to engage in a Pre-IND consultation.

If your company is making public statements about your product and COVID-19

FDA has and will continue to issue warning letters to organizations who are selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19. If you are developing a vaccine, biologic, drug, or medical device, you are required to adhere to FDA’s advertising and promotional regulations: https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products

If you have questions about your company's ongoing US regulatory obligations or if you are interested in developing your product for diagnostic or therapeutic use for COVID-19, contact Facet:
+1.610.222.6326 — INFO@FACETLS.COM

Pink Sheet's publisher has given Facet clients access to it's free COVID-19 Portal