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Regulatory Update, August 2017

Tuesday, August 1, 2017

FDA Draft Q&A Guidance on Electronic Records and Electronic Signatures

In the June 21, 2017, Federal Register, the FDA announced the availability of a draft guidance for industry titled, ‘‘Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.’’ This document pertains to sponsors, clinical investigators, institutional review boards (IRB), CRO and other interested parties who use electronic records, electronic signatures and electronic systems in FDA-regulated clinical investigations and who send certain required information to the FDA or others who keep certain required records and make them available during FDA inspections.

It provides guidance on the use of electronic records and electronic signatures under the FDA’s regulations in clinical investigations of medical products. Its foundation is the guidance for industry titled, ‘‘Part 11, Electronic Records; Electronic Signatures—Scope and Application’’ that was issued in August 2003 (and that pertained to manufacturing activities) and this new document expands those scope and application limitations to FDA-regulated clinical investigations conducted under 21 CFR parts 312 and 812.

The FDA’s overall approach to the 2003 part 11 guidance was to provide a narrow and practical interpretation of part 11 requirements. The FDA reminds sponsors, however, that records must still be maintained or submitted in accordance with the underlying predicate rules, and the FDA can take regulatory action for noncompliance with such predicate rules. In addition, the FDA continues to encourage sponsors and other regulated entities to use a risk-based approach, as introduced in the 2003 part 11 guidance and further described in this draft guidance, when deciding to validate electronic systems, implement audit trails or archive required records for clinical investigations. The draft guidance clarifies and expands upon recommendations for applying and implementing part 11 requirements, as appropriate, in the current environment of electronic systems used in clinical investigations.

The draft guidance discusses the following: (1) procedures that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and are considered to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper, and (2) the use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records and archive records that are pertinent to clinical investigations conducted under parts 312 and 812.

Submit either electronic or written comments by August 21, 2017. Submit electronic comments at www.regulations.gov (enter the Docket Number below in the Search box). Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Identify your comments with Docket No. FDA–2017–D–1105. The FDA also has instructions on how to submit confidential information. If those instructions are not followed, any submitted confidential information will be made public. This draft guidance is presented as both a “Proposed Rule” and as “Other.” Readers interested in submitting comments should review the other comments (if any) in the Docket to determine how best to submit yours (in one category or in both).

FDA Draft Guidance on Developing Kidney Transplantation Drugs

In the March 23, 2017, Federal Register, the FDA announced availability of a draft guidance titled, “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.” The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation. When made final, the guidance will represent the FDA’s current thinking on this topic.

DGF, presenting as suboptimal renal function immediately after kidney transplantation, is a manifestation of ischemia-reperfusion injury (IRI) in the transplanted kidney allograft. DGF generally is defined as need for dialysis within seven days of transplantation, although other definitions have also been published in the literature, including:

  • The need for one or more hemodialysis treatments following transplantation (not limited to seven days) before the onset of graft function;
  • Days to reach a calculated estimated glomerular filtration rate of greater than or equal to 10 milliliters (mL) per minute (min) post-transplantation; and
  • Creatinine reduction ratio between day zero and day seven of less than 70%.

The main reason to prevent DGF is to avoid the need for dialysis. Dialysis is a choice of last resort and puts the graft at risk because of potential hypotension, risk of thrombosis, increase in hospitalization and worse clinical outcome, as reported in various publications. It is further reported that there is a long-term detrimental association between DGF and important graft outcomes like graft survival, acute rejection and renal function. The draft guidance offers the FDA’s current thinking on development programs for drugs to prevent DGF. It describes efficacy and safety considerations and suggests study design and primary and secondary efficacy endpoints.

Although the due date for comments on this draft guidance has passed, comments may be submitted at any time. They may be used when the document is reviewed for updating or other purposes. Submit comments as described above. Identify comments with Docket No. FDA-2016-D-4460. 


The Regulatory Update is excerpted from Research Practitioner, Volume 18, Number 04, July-August 2017.

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