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Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS).
- Format:
- Book
- Government document
- Language:
- English
- Subjects (All):
- Somatic cells.
- Cellular therapy--United States.
- Cellular therapy.
- Drug approval--United States.
- Drug approval.
- United States.
- Physical Description:
- 1 online resource (ii, 36 pages)
- Other Title:
- Content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS)
- Place of Publication:
- Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008]
- Notes:
- Title from PDF title page (viewed on Apr 24, 2009).
- "April 2008."
- Includes bibliographical references (pages 27-29).
- OCLC:
- 319176343
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