Please provide guidance (CHOOSE ONLY ONE SELECTION).

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1. An IND (Investigational New Drug Application) is required anytime a sponsor wants to conduct a clinical trial of an unapproved drug in the U.S. This includes an APPROVED drug if it is for an unapproved indication or use. An IND would be required in order to conduct a clinical trial if the drug is any of the situations below EXCEPT ONE. Pick the one that DOES NOT require an IND.

(a) A drug in a new dosage form

(b) A new chemical entity

(c) A drug being considered for a new dosage level

(d) A generic drug

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(2) Biologics are defined as substances derived from or made with the aid of living organisms and include all of the following except one. Which item listed is NOT a biologic? (Pick the one that is not regulated as a biologic.).

(a) Silver dental filling material

(b) Vaccines

(c) Antitoxins

(d) Blood products

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(3) All of the terms EXCEPT ONE describe special designations which are available to applicants who wish to speed the development and availability of drugs. Pick the term that IS NOT a special designation.

(a) Accelerated Approval

(b) Phase I Study

(c) Priority Review

(d) Breakthrough Therapy

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(4) A food additive is any substance, the intended use of which results or may reasonably be expected to result - directly or indirectly - in its becoming a component or otherwise affecting the characteristics of any food.One example would be xanthan gum added to salad dressing.

(a) True

(b) False

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(5) A study that defines the blood levels of a new drug innormalsubjects would be considered in which phase of investigation?

(a) Phase I

(b) Phase II

(c) Phase III

(d) Phase IV

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(6) Investigators may discard unused clinical supplies from a clinical trial without further documentation or may retain them for future use in their clinical practice if so desired.

(a) True

(b) False

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(7) An investigator may delegateanystudy responsibility to any member of his/her support staff.

(a) True

(b) False

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(8) For a pharmaceutical manufacturer to place a product on the market for human use in the US, the manufacturer must follow a multiphase procedure and assure that certain scientific benchmarks are satisfied as part of the review process.

(a) True

(b) False

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(9) A clinical protocol describes the conduct of a clinical research study, including study objectives, trial design, selection of study subjects and how to carry out the study.

(a) True

(b) False

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(10 ) A combination product as defined in 21CFR3.2(e) is a combination of two or more different types of regulated products.

(a) True

(b) False

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(11) A person, corporation or agency acting as an independent contractor for the sponsor and who assumes one or more of the sponsor's obligations is known as __________________.

(a) Site consultant

(b) Contract research organization

(c) Investigator

(d) Institutional review board

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(12) According the chapter assigned in the RAPS Regulatory Affairs text book, written observations from a site inspection are documented on a Form FDA 482.

(a) True

(b) False

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(13) There is no limit to what an FDA inspector can collect during an inspection, including financial records, photographs, all personnel data and all of the company's sales data.

(a) True

(b) False

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(14) The two pillars of substantial equivalence are:

(a) Indications for use and product popularity

(b) Intended use and technological characteristics

(c) Intended use and cost to manufacture

(d) Integrity of patent and indication for use

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SELECT the correct options for below.

(15) At the end of all FDA inspections and following the completion of the Establishment Inspection Report, the inspection will be classified using the following categories. Select only the correct types of classifications and don't select incorrect ones.

(a) VAI or Voluntary Action Indicated

(b) GII or Government Intervention Indicated

(c) NAI or No Action Indicated

(d) PAI or Penalty Action Indicated

(e) HAI or Harsh Action Indicated

(f) OAI or Official Action Indicated