Capitol with hecker associates logo
Split World Map

Hecker & Associates, LLC

Product Development Experience
Regulatory Strategy
US Agent
Seminars and Events

307 North Garfield St.
Arlington, VA 22201-1261



Facebook Logo

US Agent

Picture of Sandra J Hecker
FDA requires that Sponsor companies conducting clinical trials in the US must have a US address or office, or the Sponsor must interact with FDA through a “US Agent.” Sandy specializes in being a US Agent given her long experience working internationally and with FDA. She ensures the initial US clinical trial application (IND) is complete and concise, facilitating its prompt, successful review, and ability to proceed.

Since INDs are filed electronically to FDA in eCTD format, Sandy works with the Sponsor to determine best placement of its data, given its unique project’s history, with an eye toward efficient updating of the IND over the life of the project. Although FDA provides a mapping chart citing where in the CTD IND information required by US regulation should be placed, the guidance is vague, particularly about where to put clinical data from earlier studies conducted elsewhere in the world. Best placement depends on many factors, which Sandy can help decide. Also, unlike many countries for which a new clinical trial application is filed for each protocol, the US process is for all protocols for the project to be filed to the same IND, meaning consistent and efficient filing of data throughout the life of the IND is critically important for eventual review of the marketing application.

Once an IND is filed, Sandy maintains the IND/CTA by filing protocol amendments, annual reports/DSURs, time-sensitive safety information for clinical trial patients, FDA meeting requests, and ensures all project regulatory requirements are met. Sandy frequently interacts with FDA staff to ensure projects stay on track.