The Association of Clinical Research Professionals

Regulatory Comments

FDA – Comments Submitted to FDA on Considerations for Pediatric Studies for Drugs and Biological Products

Regulatory CommentsFebruary 9, 2015

Comments Submitted to FDA on Considerations for Pediatric Studies for Drugs and Biological Products. (Docket Number: FDA-2013-D-1275-0001).

NIH – Comments Submitted to NIH on Policy on the Use of a Single Institutional Review Board for Multi-Site Research

Regulatory CommentsJanuary 29, 2015

Comments Submitted to NIH on Policy on the Use of a Single Institutional Review Board for Multi-Site Research. (NOT-OD-15-026).

OPHS – Comments Submitted to OPHS on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care

Regulatory CommentsJanuary 22, 2015

Comments Submitted to OPHS on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care. (HHS-OPHS-2014-0005). Click here to read the comments.

FDA – Comments Submitted to FDA on Rare Pediatric Disease Priority Review Vouchers

Regulatory CommentsJanuary 16, 2015

Comments Submitted to FDA on Rare Pediatric Disease Priority Review Vouchers. (Docket Number: FDA-2014-D-1461-0001). Click here to read the comments.