This document references:
21 CFR PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION
Published by HHS
on
April 1, 2014
(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...
This document references:
21 CFR PART 50 - PROTECTION OF HUMAN SUBJECTS
Published by HHS
on
April 1, 2018
(a) This part applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical...
This document references:
21 CFR PART 56 - INSTITUTIONAL REVIEW BOARDS
Published by HHS
on
April 1, 2019
(a) This part contains the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and...
This document references:
21 CFR PART 812 - INVESTIGATIONAL DEVICE EXEMPTIONS
Published by HHS
on
April 1, 2018
(a) The purpose of this part is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices...
This document is referenced by:
AFI 99-103 - CAPABILITIES-BASED TEST AND EVALUATION
Published by AIR FORCE
on
November 18, 2019
Purpose of Test and Evaluation. The purpose of test and evaluation is to ensure DoD acquires systems that work and meet specified requirements. Additionally, overarching functions of test and...
This document is referenced by:
AFI 44-102 - MEDICAL CARE MANAGEMENT
Published by AIR FORCE
on
March 17, 2015
Purpose. This instruction provides guidance for the general delivery of patient care and management of clinical services throughout the Air Force Medical Service (AFMS).