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Guidance for FDA reviews and sponsors : : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs).
2008
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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).
2008
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Guidance for industry and FDA staff : expedited review of premarket submissions for devices
2008
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Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
2008
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Guidance for industry : biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components
2008
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Guidance for industry : certain human cells, tissues and cellular and tissue-based products (HCT/Ps) recovered from donors who were tested for communicable diseases using pooled speciments or diagnostic tests
2008
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Guidance for industry : CGMP for phase 1 investigational drugs
2008
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Guidance for industry : considerations for allogeneic pancreatic islet cell products
2008
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Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
2008
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Guidance for industry : contents of a complete submission for the evaluation of proprietary names
2008
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