, 5 tweets, 1 min read Read on Twitter
THREAD: We’re getting many questions about when #FDA can continue to accept medical product applications during the lapse in funding. The questions tonight relate to one particular biotech firm. However, I'm addressing the issues generally, and not specific to one product.
For products covered by a user fee program, if the product sponsor submitted the application and paid any required fees before the lapse, FDA can use its limited carryover user fee funding to continue reviewing the application.
However, during the lapse, FDA cannot accept new medical product applications that require a fee payment. We are not allowed to accept new user fees. In these cases, sponsors will need to wait until the lapse is over to submit their applications to FDA for review.
More specifically, for products not covered by a user fee program, like most blood and allergenic extract products, FDA does not have carryover user fee funding to continue reviewing pending or accepting new applications.
These product categories are not associated with a user fee program. As a result, during the lapse, FDA activities for products are limited to emergency work involving safety of human life, such as monitoring for adverse events and, if warranted, taking action to protect patients
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