Recommendations Directed to FDA

Attachment E - Recommendations on FDA draft Real-World Evidence guidance
Attachment C: SACHRP Comments on FDA draft guidance “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers”
Attachment B: Commentary on FDA Draft Guidance, “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products,” released December 9, 2014, docket number FDA-2013-D-1275-0002
Attachment A: SACHRP Commentary on the FDA Draft Guidance Entitled, "Informed Consent Information Sheet; Guidance for IRBs, Clinical Investigators and Sponsors," released July 15, 2014, docket number FDA-2006-D-0031
Attachment A: SACHRP comment regarding the June 4, 2013 FDA Request for Comment relating to the availability of masked and de-identified non-summary safety and efficacy data
Attachment B: Comments on OHRP and FDA Draft Guidance Documents Regarding IRB Transfers
Attachment B: Recommendation on Single Patient Treatment Use
Attachment A: Recommendation on Applicability of FDA Regulations for IRBs
Attachment C: Approved by SACHRP July 20, 2011- SACHRP Recommendation regarding application of 45 CFR 46 and 21 CFR 56 to early processes in research, such as identifying potential subjects, contacting subjects and recruiting subjects