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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 18, 2013 FBO #4254
SOLICITATION NOTICE

B -- Evaluate the therapeutic equivalence of generic sodium ferric gluconate iron complex Nulecit™ and its RLD Ferrlecit® - FDA-SOL-1120929

Notice Date

7/16/2013
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-SOL-1120929
 

Archive Date

8/31/2013
 

Point of Contact

Natalie Mitchell, Phone: 3018279606
 

E-Mail Address

natalie.mitchell@fda.hhs.gov
(natalie.mitchell@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Solicitation The objective of this study is to evaluate the therapeutic equivalence of generic sodium ferric gluconate iron complex Nulecit TM and its RLD Ferrlecit®. Specific aims are: 1) compare reticuloendothelial system (RES) uptake of RLD and generic; 2) compare biodistribution of the RLD and generic in animal models; 3) conduct in-vivo study to compare plasma NTBI levels and oxidative stress after i.v. administration of RLD and generic in healthy subjects or patients. This study is part of post-market surveillance that can help address potential concerns regarding the quality of generic iron complex products and support the Agency's review standards.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1120929/listing.html)
 

Place of Performance

Address: FDA, Rockville, Maryland, 20855, United States

Zip Code: 20855
 

Record

SN03118319-W 20130718/130716235754-4ff6dcf9ec53803a96430d87b79425ef (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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