MODIFICATION
A -- Radiopharmaceutical Development & Production
- Notice Date
- 12/17/2007
- Notice Type
- Modification
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, MD, 21702, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- S08-062
- Response Due
- 1/11/2008
- Archive Date
- 1/26/2008
- Point of Contact
- Shannon Jackson, Supervisor, Research Subcontracts, Phone 301-228-4022, Fax 301-228-4037
- E-Mail Address
-
sjackson@mail.ncifcrf.gov
- Description
- The Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI) would like to engage subcontractors that are able to produce and distribute PET and SPECT radiopharmaceuticals to support non-clinical studies and both small early phase trials and larger trials on a unit dose basis to regional and national sites. A key requirement is the ability to produce and distribute doses to support trials conducted under authority of an Investigational New Drug (IND) or Radioactive Drug Research Committee (RDRC), including multi-center. The products may be produced employing the subcontractor?s established procedure, a published procedure, the procedure submitted in an NCI IND, or by a subcontractor-developed procedure that synthesizes the desired product. The procedure must be provided for submission to the Food and Drug Administration (FDA) and accepted by the FDA or a Drug Master File (DMF) may be filed but also must be accepted by the FDA.
- Place of Performance
- Address: Vendor site
- Zip Code: 00000
- Country: UNITED STATES
- Zip Code: 00000
- Record
- SN01470976-W 20071219/071217223229 (fbodaily.com)
- Source
-
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