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 | FDA info RE phase 1 |  |
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hedgehog
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Guidance for Industry, Investigators, and Reviewers
Exploratory IND Studies "This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Alternative approaches can be used if the approach satisfies the requirements of the applicable statutes and regulations. Discussions of an alternative approaches can be scheduled by contacting the FDA staff responsible for implementing this guidance. If the appropriate FDA staff cannot be located, contact can be made using the telephone number listed on the title page of this guidance." FDA website or download complete article (pdf) 
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