Guidance

US FDA seeks comments on annual guidance agenda

The US Food and Drug Administration is seeking comment from the public on its annual guidance document agenda, which lists the topics for future guidance that it may develop or revise during the coming year¹.

The list was published under the agency's good guidance practices for ensuring that the public is involved in the development of its guidance documents and for enhancing public understanding of the availability, nature and legal effect of the guidances. The guidance documents are organised by the issuing centre or office within the FDA, and are further grouped by topic categories. Comments can be submitted at any time.

Center for Biologics Evaluation and Research

Guidance topics or documents listed in the Center for Biologics Evaluation and Research section of the agenda include:

• pre-storage leukocyte reduction of whole blood and blood components intended for transfusion;
• assessment of donors of blood and blood components for transfusion transmitted malaria risk;
• current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments;
• devices involved in manufacture, storage and administration of cellular products and tissues; and
• preparation of investigational device exemptions and investigational new drugs for tissue-engineered and regenerative medicine products.

Center for Devices and Radiological Health

Guidance listed in the agenda's Center for Devices and Radiological Health section include:

• implementation of medical device establishment registration and device listing requirements established by the FDA Amendments Act of 2007;
• using Global Harmonization Task Force guidance on clinical evaluation, quality management system requirements concerning process validation, third party inspections and summary technical documentation;
• risk management information in premarket submissions;
• electronic medical device reporting;
• adverse event reporting for in vitro diagnostics;
• disputes concerning medical device user fee payments or refunds; and
• coronary drug-eluting stents.

Office of the Commissioner

Listed in the agenda's section for the Office of the Commissioner are, among other things, guidance topics on the following:

• data retention when subjects voluntarily withdraw from FDA-regulated clinical trials;
• a guide to informed consent;
• certifications to accompany drug and biological product and device applications: compliance with section 402(j) of the Public Health Service Act;
• good importer practices; and
• private labs.

Center for Drug Evaluation and Research

Finally, the section under the Center for Drug Evaluation and Research includes guidance on the presentation of risk information in medical device and prescription drug promotion.

References

1. Federal Register, 7 August 2008, 73(153), 46008-46020, http://edocket.access.gpo.gov/2008/pdf/E8-18126.pdf