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Fda 21 cfr 312 sponsor recordkeeping

fda 21 cfr 312 sponsor recordkeeping

TITLE 21 --FOOD AND DRUGS CHAPTER Subpart D--Responsibilities of Sponsors and Investigators · § - Investigator recordkeeping and record retention. § - Focused FDA regulatory research. §.
approval for the reporting and recordkeeping requirements contained in the Application" in part 312 (21 CFR part 312). .. Sponsor's report to FDA on findings.
Investigators and sponsors should refer to 21 CFR Parts 11, 50, 54,. 56, and 312 for a more comprehensive listing of FDA's requirements for the conduct of drug and .. Specific recordkeeping requirements are set forth at 21 CFR.
The regulations document all actions of all drug sponsors that are required under Federal law. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Skip to Common Links. IND Forms and Instructions. In the case of any discrepancy in meaning, the English version is considered official. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped, and the date, quantity, and batch or code mark of each such shipment.