The US Food and Drug Administration (FDA) has launched a new web resource, FDA Basics for Industry, which aims to help companies save time and resources in their interactions with the agency.
The site is one of 19 action items contained within the 46-page FDA Transparency Initiative report, launched by the agency late last week.
FDA Basics for Industry will provide basic information about the FDA’s regulatory processes, including information frequently requested by industry.
The Initiative also includes five other items which commit the agency to improving communications about its procedures to industry through the following actions:
• updating agency organisational charts and senior leadership personnel changes on the FDA website at least on a quarterly basis and ensuring that the level of detail provided on the charts is consistent agency-wide;
• providing links to the processes available for industry to submit general regulatory questions to each FDA Center;
• aiming, whenever practicable, to respond within five business days to general questions submitted via email about an existing policy, regulation or the regulatory process, or to acknowledge receipt of the inquiry and provide an estimated time for response;
• issuing a final version of its Strategic Priorities FY 2011-2015 by March; and
• posting on its website slide presentations delivered by FDA employees to external audiences at events sponsored or co-sponsored by the agency.
“We have heard from small and large companies about the need for the FDA to more clearly communicate about its standards and expectations – both for regulated products generally and for specific applications,” said FDA Principal Deputy Commissioner Joshua Sharfstein, chairman of the agency’s Transparency Task Force.
“Clarity and consistency are pillars of an effective regulatory system that efficiently regulates products essential to health,” added FDA Commissioner Margaret Hamburg. “In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates,” she said.
The Initiative report also includes four action items focused on improving transparency during the product application review process. They require the agency to:
• compile all FDA Center guidance and standard operating procedures on FDA employees meeting with sponsors about product applications on FDA Basics for Industry;
• describe the types of notifications provided by the agency to industry about the product application review process, and provide an overview of the processes used, in order to improve consistency within the review process;
• communicate general expectations about the circumstances in which it might be appropriate to use secure email between FDA and a manufacturer when there is a question involving the firm’s product; and
• explain how a sponsor is informed about whether the review of its product application is on track to meet the target date for FDA action. The agency says it is also willing to hold further discussions with industry about application tracking systems, and to explore the feasibility of implementing such a system at FDA.
The Initiative also includes two action items which focus on greater transparency around the guidance development process. In the first of these, Commissioner Hamburg has formed a cross-agency workgroup to identify the best practices for improving the agency’s work on guidance; and in the second, the FDA will describe how interested individuals can provide it with input about guidance development. Links providing industry with a list of guidance documents withdrawn during the past year will be made accessible in one location on the agency website, as will possible topics for future guidance development or revision.
And two further items focus on transparency of the regulations development process. First, the FDA will, after it issues a Final Rule, conduct outreach to the affected stakeholders as part of the Rule’s implementation if it imposes substantial new obligations. Second, the agency will work with the Department of Health and Human Services (HHS) and the Office of Management and Budget (OMB) to improve the accuracy of the timetables included in the FDA regulatory agenda.
The report also contains five action items aimed at improving communications with importers, and five draft proposals to improve FDA’s transparency to regulated industry. The latter include publishing a timeline on the FDA website for high-priority guidance documents in development and plans for the agency to disclose dates for publication of the draft guidance, receipt of public comments, and publication of the final guidance. It is seeking public comment on these draft proposals within 60 days.
