What We Do CDER SBIA is often the first stop for a small pharmaceutical business trying to contact the Agency. Our goal is to help small […]

Delivery Method: VIA Electronic Mail Reference #: 320-26-40 Product: Drugs Recipient: Recipient Name Dr. Vetukuri Venkata Naga Kali Vara Prasada Raju Recipient Title Managing Director & […]

Delivery Method: Via Electronic Mail – Return Receipt Requested Reference #: 320-26-39 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Eric Jon Gripentrog Recipient Title Chief […]

Delivery Method: Via Electronic Mail – Return Receipt Requested Reference #: FEI 3015892095 Product: Drugs Recipient: Recipient Name Mr. Matteo Scarpis Recipient Title CEO Eurosirel S.P.A […]

Before FDA grants the initial meeting under the RDEA Pilot Program, the Agency and the sponsor must agree on the information that FDA may disclose publicly. […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

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 […]