The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
We cannot provide estimates of review timelines. Please see our FAQ
Q: I submitted a pre-EUA or EUA request for a COVID-19 test. How long will the review take? (New 6/17)?
A: During this unprecedented public health emergency, the Agency has received an exceedingly high volume of EUA requests and is working as quickly as possible to review each request. There are hundreds of pre-EUA and EUA requests for COVID-19 tests under review and FDA continues to receive new submissions on a daily basis. To address this high volume of work, we have brought in additional scientific review staff to double the number of teams working on submissions; and we have implemented a triage program to prioritize submissions based on several factors. As a result of these efforts, by June 1, 2020, FDA had authorized over 125 diagnostic and serological tests, far exceeding the number of test EUAs issued during previous emergencies.
As explained in FDA's guidance "Emergency Use Authorization of Medical Products and Related Authorities," starting on page 18, FDA prioritizes EUA requests based on several factors that include, but are not limited to, the public health need of the product (e.g., point-of-care; high throughput), the extent to which the product would serve a significant unmet medical need (e.g., at-home specimen collection; at-home testing), and the availability and adequacy of the information concerning the likelihood that the product may be safe and effective in preventing, treating, or diagnosing the condition, as well as the availability of the product (e.g., the quantity and manufacturing capacity).
FDA strives to review Pre-EUA and EUA requests as quickly as we can. FDA will communicate with each sponsor regarding its pre-EUA or EUA request as soon as possible. The review team will be in contact with you when their review is complete or if there are questions. If you have not yet been assigned a lead reviewer for your pre-EUA or EUA request, we recommend that you refer to the available resources to help you with your planning and submitting your EUA request:
•SARS-CoV-2 IVD EUAs (Letters of Authorization and Instructions for Use/EUA Summaries)
•EUA Templates with recommendations to help facilitate EUA requests, as explained in the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
•FAQs on Testing for SARS-CoV-2
Additionally, FDA's Policy for Coronavirus Disease-2019 Tests guidance includes recommendations intended to help accelerate the availability of COVID-19 tests in the United States for the duration of the public health emergency under certain circumstances. As explained in this policy, FDA does not intend to object to the development, distribution, and use of some tests prior to or without an EUA, as outlined in the guidance. Please refer to this policy for more in
We are legally not permitted to disclose any non-public information related to any particular sponsor or submission as they are confidential. This includes whether or not a submission exists. When tests are authorized, pertinent information about the test and the authorization is made public. Please contact the manufacturer or point of contact for the status of the submission.
Please ignore my ignorance. Everyone keeps crying about the lack of positive news coming out of the company, am I correct in thinking that negative news should be passed in lot the market as well??? If so I haven’t come across any yet in the form of a RNS. I believe in this company and it’s PRODUCTS. Keep the faith if not sell up and move on..