Not all investigator-initiated clinical investigations require an Investigational New Drug (IND) application. Before contacting FDA or submitting an IND for an investigator-initiated clinical investigation, investigators should […]

Investigator’s Responsibilities This page provides the key points that investigators should consider in order to understand their responsibilities regarding an IND application. For full description of […]

Sponsors of IND applications are responsible for sending periodic updates and reports related to their applications to FDA. All submissions with IND application amendments or reports […]

Sponsors of IND applications may obtain advice and guidance from FDA at any stage of IND development. A sponsor may consult with the Agency before formal […]

Once an IND application is in effect, the sponsor of the application may amend the application as needed to ensure that the clinical investigations are conducted […]

Analgesics Drugs that relieve pain. There are two main types: non-narcotic analgesics for mild pain, and narcotic analgesics for severe pain. Antacids Drugs that relieve indigestion […]

Full drug marketing application submissions under 21 CFR subpart 314.50 and 314.54 should be directed to: Center for Drug Evaluation and ResearchFood and Drug AdministrationDocument and […]

On November 12, 2025, the President signed into law the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026. This new […]

Image By: Marty Makary, M.D., M.P.H., Commissioner of Food and Drugs 2026 is a special year for the U.S. Food and Drug Administration. It marks our […]