What FDA approval pathway applies to a Ukrainian new drug for sale in the United States?

Dear Sir/Madam,

Thank you for your question regarding drug approval in the United States. The FDA offers several pathways for marketing a new drug. The primary route is the New Drug Application (NDA), where you submit comprehensive data from preclinical and clinical studies to prove safety and efficacy. Other options include abbreviated pathways such as the 505(b)(2) application if your drug relies on existing data, or generic drug applications (ANDA) for bioequivalent products.

Typical NDA review timelines average about 10 months under standard review or 6 months under priority review, but the total drug development process often takes many years prior to submission. You must submit detailed data including laboratory, animal, and human clinical trial results. Regarding sponsorship, while a U.S.-based sponsor or agent is generally needed for FDA filings, foreign companies can work through authorized U.S. agents without requiring a physical presence in the U.S.

Best regards.