What statement must the label of all investigational drugs bear?
(a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement “Caution: New Drug – Limited by Federal (or United States) law to investigational use.”
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.
Are there special labeling requirements for investigational devices?
Under § 812.5 an investigational device or its immediate package must bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor; the quantity of contents, if appropriate; and. the statement, “CAUTION Investigational device.
What are the labeling requirements of an investigational medicinal product which is used in the clinical trial?
These labels must include instructions for use, mode and route of drug administration, product strength, storage requirements and expiry dates, amongst other information. Each label is unique to the individual patient and must also be specific to the trial and country in question.
Which of the following should not be included on the label of an investigational device?
The labeling of an investigational device shall not bear any statement that is false or misleading in any particular and shall not represent that the device is safe or effective for the purposes for which it is being investigated.
Which of the following does 21 CFR Part 312 deals with?
Content: This part contains procedures governing the use of investigational new products including the submission to, and review by, the FDA.
What part of 21 CFR deal with drugs?
Chapter II — Drug Enforcement Administration.