Investigator Initiated Study / American Regent

Investigator Initiated Study

Investigator Initiated Study Information and Submission

American Regent, Inc. is committed to supporting Investigator Initiated Studies (IIS) to address medically and scientifically sound research for the management of iron deficiency anemia (IDA), related to Injectafer® (ferric carboxymaltose injection).

Please review the following guidance and the Investigator Initiated Studies Guidance Document below to submit an IIS proposal:

Click here to review Investigator Initiated Studies Guidance

Click here to download the Investigator Initiated Studies Proposal Synopsis Form

Please submit the completed Proposal Synopsis Form and supportive documentation to IST@americanregent.com

Once American Regent, Inc. receives the completed proposal, it will be reviewed by our IIS committee in accordance with our company policy. The investigator will then be contacted once the committee has completed its review.

Contact Us

Request for Medical Information Request a Grant Investigator Initiated Study Request a Certificate of Analysis Expanded Access Policy

P: 800-645-1706
(8:00am–6pm Monday - Thursday and Friday 8:00am–4pm Eastern Time)
P: 800-734-9236
F: 610-650-0170
E: pv@americanregent.com

Adverse Drug Events (ADEs) may be reported to the FDA:
Phone: 1-800-FDA-1088
Web: www.fda.gov/medwatch
P: 888-354-4859
E: pqc@americanregent.com
P: 888-354-4855
(9am–5pm Eastern Time, Monday - Friday)
E: ma@americanregent.com

For drug information outside of normal business hours that cannot wait until the next day, please call:

P: 877-845-6371
American Regent, Inc.
5 Ramsey Road
Shirley, NY 11967

P: 631-924-4000
F: 631-924-1731

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