As a result of the lapse in funding the FDA will not have legal authority to accept user fees assessed for FY 2019 and will not be able to accept any regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period.
Certain submissions are still accepted by FDA and will be processed accordingly. The examples of such submissions are as follows:
- General correspondence
- Investigational new drugs applications (INDs)
- Annual reports
- NDAs or BLAs that only have orphan designated indications, or theirs supplements
- Applications for which FDA has waived the application fee
FDA assures that the critical public health activities such as protection of consumers and patients from harmful products, medical product recalls or imminent threats to the safety of humans will continue to be carried out during this period.
Asphalion has extensive experience in FDA Submissions. Contact us for US regulatory support at fda@asphalion.com
