Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food and Drug Administration

摘要

Current regulations prohibit the US Food and Drug Administration (FDA) from publicly disclosing the existence of pending New Drug Applications (NDAs) or Biologies License Applications (BLAs) unless previously publicly disclosed or acknowledged. Applicants may disclose applications in press releases, Securities and Exchange Commission (SEC) filings, or in other media; how frequently they do so is not known.