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21 CFR 58 Good Laboratory Practice Regulations Reg. No. 58.1Regulatory Text Subpart A General Provisions Scope (a) This part prescribes good laboratory practices for conducting nonclinical laboratory
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What is 21cfr58?
21cfr58 refers to the regulations set forth in Title 21 of the Code of Federal Regulations, Part 58, which pertains to Good Laboratory Practice for non-clinical laboratory studies.
Who is required to file 21cfr58?
Any organization conducting non-clinical laboratory studies that support applications for research or marketing permits to the Food and Drug Administration (FDA) is required to comply with 21cfr58.
How to fill out 21cfr58?
The process of filling out 21cfr58 involves following the guidelines outlined in Title 21 of the Code of Federal Regulations, Part 58, which includes maintaining proper documentation, conducting studies in accordance with good laboratory practices, and submitting accurate and complete reports.
What is the purpose of 21cfr58?
The purpose of 21cfr58 is to ensure the quality and integrity of non-clinical laboratory studies conducted for the purpose of gaining FDA approval for research or marketing permits.
What information must be reported on 21cfr58?
Information that must be reported on 21cfr58 includes details of the study design, protocol, procedures, data collected, results, and conclusions.
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