Which of the following does 21 CFR Part 312 deal with?
Which of the following does 21 CFR Part 312 deal with?
Content: This part contains procedures governing the use of investigational new products including the submission to, and review by, the FDA.
Can an investigational drug be a controlled substance?
An investigator must take adequate precautions to prevent theft or illegal diversion of investigational drugs that are controlled substances.
What is FDA’s definition in 21 CFR 312 of an investigational new drug?
An institutional review board (IRB), as defined in § 56.102(g) of this chapter and subject to the requirements of part 56 of this chapter, is one type of IEC. Investigational new drug means a new drug or biological drug that is used in a clinical investigation.
What is 21 CFR in pharma industry?
21 CFR Rules are a set of rules which govern or regulate the management and usage of electronic records in pharmaceuticals and medical devices.
What are the 3 phases an investigational drug goes through prior to submitting a new drug application?
1- Preclinical (animal) testing. 2-An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials. 3-Phase 1 studies (typically involve 20 to 80 people). 4-Phase 2 studies (typically involve a few dozen to about 300 people).
Who can administer an investigational drug?
FDA Regulations for Control of Investigational Drugs Per §312.61, investigators may only administer investigational drugs to participants under the investigator’s personal supervision or the supervision of a sub-investigator responsible to the investigator.
Which parts of 21 CFR deal with drugs?
21 CFR Chapter I – FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES.
What is the main difference between Annex 11 and 21 CFR Part 11?
While the FDA 21 CFR covers US-based pharmaceutical companies, Annex 11 is a Good Manufacturing Practice (GMP) guideline in the European Union. 21 CFR part 11 is a regulation of the FDA that applies to drug manufacturers, biotech companies and other regulated industries.
