FDA Guidance Documents on GCP: Periodic Review

FDA Comment Period Proposed Guidance

FDA Comment Period for Proposed Guidance on Financial Disclosure

The FDA has released a number of guidance documents in the past few years that gives the Agency’s current thinking on Good Clinical Practice and other regulatory issues. Some of these documents change the “conventional wisdom” on conducting clinical trials. One document: “FAQs on the Form FDA 1572, Statement of the Investigator,” changes the way we look at putting research coordinators on the FDA 1572. Another document, “Adverse Event Reporting to IRBs,” changes the old rule of thumb to Always report a serious adverse event (SAE) to the IRB within 15 days (or less). Currently, FDA is soliciting public comment on the Draft Guidance Document, “Financial Disclosure by Clinical Investigators.” The comment period is the opportunity for the public, researchers, and regulated industry to comment on FDA’s guidance on financial disclosure and compliance with 21 CFR Part 54.

FDA guidance document periodic review

Periodic Review of SOPs

Why am I bringing up the issue of guidance documents?
Every organization that writes standard operating procedures (SOPs) to maintain compliance with FDA regulations should have a policy in place to perform Periodic Review of those procedures. Any periodic review should include a review of guidance documents from FDA and other regulatory agencies. There have been more than one Form FDA 483, Inspectional Observations, that have listed the failure to perform Periodic Review of SOPs. Look at the “Reference” section of your SOPs. Is it current? Are you keeping up with what FDA and EMA are saying?

Here are several documents that have been released of late that I think should be on any periodic review of SOPs:

Draft: Financial Disclosure by Clinical Investigators

FAQs on the FDA 1572

Supervisory Responsibilities of Investigators

Adverse Event Reporting to IRBs

MHRA: Clinical Laboratories

EMA: Pharmacovigilance and Risk Management

Finally, I think it is important to return to a final rule and look at the “preamble.” This is the discussion of a proposed rule (regulation) and the public comments on it during the rulemaking process. Here is the lengthy preamble to the 1987 rewrite of the IND regulations, 21 CFR Part 312. In part 3 of the preamble, you have to scroll all the way down to access part 2 and then scroll all the way down to get to part 3, you can see what FDA said about transferring responsibilities to a CRO. Very interesting reading:

Part 312 Preamble

(Graphic on upper left is “Freedom of Speech,” by Norman Rockwell.)

8 July UPDATE: There is an interesting FDA Press Release regarding new anti-smuggling measures and a new Draft Guidance Document on dietary supplement ingredients.

On The Blogroll: FDA Matters discusses the new FDA import initiative

The Medicine Show on Forbes discusses the decline in drug approvals.


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