FDA Issues Draft Guidance Document on Clinical Trial Adverse Events


FDA draft guidance adverse events

FDA Draft Guidance on Clinical Trial Adverse Event Reports

FDA issued a draft guidance document on adverse event reports on 28 September 2010. This opened a 90-day public comment period for FDA’s consideration on the draft guidance ending on 28 December 2010. (Comments may be made at any time but need to be made in the 90-day comment period to be included for FDA’s review as they prepare the final document.) The draft guidance, Guidance for Industry and Investigators- Safety Reporting Requirements for INDs and BA/BE Studies was issued at the same time as the final rule for re-writing 21 CFR 312.32, IND Safety Reporting, was published in the Federal Register (See previous post, FDA Clarifies Adverse Event Reports for Clinical Trials, 10 October 2010). In this final rule FDA adopted definitions from the International Conference on Harmonization, implemented new reporting requirements for bioavailability and bioequivalence (BA/BE) studies, and clarified what sponsors need to report to the FDA. One important clarification notes the following:

“The sponsor must report an adverse event as a suspected adverse reaction only if there is evidence to suggest a causal relationship between the drug and the adverse event”

The draft guidance document explains that FDA does not want isolate reports that may be of no use in determining the drugs safety. The document states:

“The new requirements clearly distinguish circumstances in which it is appropriate to submit individual cases and circumstances in which cases should be aggregated and compared to a control group.”

FDA adverse events

When to Report Adverse Events to FDA

The draft guidance goes on to explain the circumstances when sponsors should send safety reports to the agency. In the definitions section FDA expands on the definitions found in the final rule including for the terms “serious” and “unexpected.” The draft guidance also provides sponsors with important guidance on two important points that will undoubtedly draw a number of responses. They are:

Review of Safety Information, including the scope of possible sources of safety information, and;

Monitoring the Safety Database and Submitting IND Safety Reports. Here FDA describes a number of situations where a sponsor should report safety information to FDA. They include individual events; one or more events, and an aggregate analysis of specific events. The draft guidance also discusses reporting study endpoints and SAEs that are not study endpoints.

FDA draft guidance adverse events

How Should Clinical Trial Adverse Events be Reported to FDA?

The importance of the comment period: FDA issued the original draft rule for safety reports in 2003. There were a number of comments that suggested improvements to the draft rule. As a result, FDA significantly changed the final rule issued this September. Public comments are an integral part of the process for rule making and writing guidance documents. The input from industry, patient advocates, researchers, and GxP professionals is essential for finalizing a guidance document that will give the agency the tools it needs in determining a drug’s safety.

You can access the final rule, the draft guidance document, and information about making comments (please don’t be intimidated by the complex, lengthy title):

Draft Guidance & Final Rule

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This just in: Request for Comments- Exculpatory Language Used in Informed Consent, a joint FDA and OHRP draft guidance document (September 2011)
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In news from GxP Perspectives. I will be participating in the conference, Developing CAPAs in the GCP Environment on January 18-19, 2011 in Arlington, VA.

Please join GxP Perspectives on LinkedIn at:

GxP Perspectives LinkedIn Group

In news from the blogosphere: Read an interview on the Biotech Blog with John Avellanet, author of the blog, Compliance Zen. John has a new book out, which I hope to review soon for the blog, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine.

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