Posted by Michael Wonder on 04 Jun 2019
Public disclosure of the filing of new drug and therapeutic biologics applications with the US Food and Drug Administration
3 June 2019 - Current regulations prohibit the US FDA from publicly disclosing the existence of pending new drug applications or biologics license applications unless previously publicly disclosed or acknowledged.
Applicants may disclose applications in press releases, Securities and Exchange Commission filings, or in other media; how frequently they do so is not known.
