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21 cfr 312 60

21 cfr 312 60

Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION Subpart D - Responsibilities of Sponsors and Investigators Section - General.
PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief.
Subpart A--General Provisions · § - Definitions and interpretations. § - Labeling of an investigational new drug. § - Promotion of investigational.

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Skip to Common Links. In the case of any discrepancy in meaning, the English version is considered official. Subpart D--Responsibilities of Sponsors and Investigators. Note: If you need help accessing information in different file formats, see. Subpart D--Responsibilities of Sponsors and Investigators. Food and Drug Administration. Subpart B--Investigational New Drug Application IND. 21 cfr 312 60