21 CFR Parts 312, 314, 600, and 601: Fill out & sign online

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What is 21 CFR Part 312?

312.1 Scope. (a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (INDs).

What is 21 CFR 314?

eCFR :: 21 CFR Part 314 -- Applications for FDA Approval to Market a New Drug.

How many parts are in 21 CFR?

10 parts of 21 CFR medical device manufacturers must know Part 820 - Quality System Regulation (QSR): This is often referred to as the Good Manufacturing Practices (GMP) regulation for medical devices.

What is the focus of 21 CFR 812?

This part of the Code of Federal Regulations (CFR) contains the procedures and requirements governing the conduct of clinical research of devices. This research primarily addresses the safety and effectiveness of Investigation Device Exemptions (IDE).

What does 21 CFR 312.32 provide regulations about?

Under 21 CFR 312.32(c), as it currently exists, a sponsor must provide expedited reporting to FDA and to all participating investigators of any suspected adverse reaction that is both serious and unexpected (a serious and unexpected suspected adverse reaction (SUSAR)).

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What are the 3 phases an investigational drug goes through?

Phase 1 studies (typically involve 20 to 80 people). Phase 2 studies (typically involve a few dozen to about 300 people). Phase 3 studies (typically involve several hundred to about 3,000 people). The pre-NDA period, just before a new drug application (NDA) is submitted.

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