Regulatory Comments Archives

FDA – Comments submitted regarding Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”)

Regulatory CommentsMarch 29, 2016

Comments submitted regarding Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals"). (Docket number: FDA-2015-D-4803). Click here to read the comments and impact on ACRP Members.

FDA – Comments submitted regarding Clinical Outcome Assessment Compendium

Regulatory CommentsMarch 14, 2016

Comments submitted regarding Clinical Outcome Assessment Compendium. (Docket number:FDA-2015-N-5106). Click here to read the comments and impact on ACRP Members.

CIOMS – Comments submitted regarding the public consultation on the Revision of CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects

Regulatory CommentsMarch 1, 2016

Comments regarding the public consultation on the Revision of CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects.

FDA – Comments submitted regarding Safety Assessment for IND Safety Reporting

Regulatory CommentsFebruary 16, 2016

Comments submitted to the FDA regarding Safety Assessment for IND Safety Reporting. (Docket number: FDA-2015-D-4562).

EMA – Comments submitted regarding Guideline for good clinical practice E6(R2)

Regulatory CommentsFebruary 3, 2016

Comments submitted regarding Guideline for good clinical practice E6(R2). (Identifier:EMA/CHMP/ICH/135/1995). Click here to read the comments and impact on ACRP Members.