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U.S. Department of Health and Human Services

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Phase III Progress Report

FDA issued the Phase III Report, entitled "FDA Transparency Initiative: Improving Transparency to Regulated Industry", in January 2011, and it solicited public comments on the report for 60 days. The report contained 19 action items to foster: (1) better communication with industry, (2) a more transparent product application review process, (3) greater transparency and/or efficiency in the Agency's development and issuance of guidance and regulations, and (4) better communication with importers.

The report also contained the following draft proposals for public comment: (1) disclosing, for certain high priority guidance documents in development, a timeline from the start of the Agency’s work on the draft guidance to publication of the final guidance, (2) posting on the FDA Web site a list of presentations given by FDA employees to external audiences, (3) informing submitters if an appeal request will be reviewed by the FDA Commissioner and when a decision may be expected, (4) reviewing existing procedures to evaluate importers, or third parties working on behalf of importers, who file information electronically about products offered for import, and (5) initiating a planning process to develop a web-based system that provides information about importing requirements.

FDA has already implemented a number of the Phase III action items, and the Agency is working diligently to implement the others. The Commissioner, however, is still considering the public comments regarding the draft proposals, as well as the their operational feasibility, resource requirements, and priority relative to each other and other Agency initiatives. FDA invites the public to track our progress by bookmarking this page. This page will be updated as our efforts progress.

Completed Action Items:

Action Item 1:  FDA will develop a web-based resource called FDA Basics for Industry that will provide basic information online about the regulatory process governing FDA-regulated products, and include information that is frequently requested by industry. 
Link: FDA Basic for Industry

Action Item 3:  Each Center has a process for industry to submit general regulatory questions, and for directing inquiries to individuals with additional expertise, if necessary. Links to these processes will be made available on FDA Basics for Industry.
Link: Regulatory Process

Action Item 5:  In September 2010, FDA issued its “Strategic Priorities FY 2011-2015” in draft form for public comment.  FDA will issue a final version of the “Strategic Priorities FY 2011-2015” by March 2011.
Link: Strategic Priorities

Action Item 6:  FDA will post on the FDA Web site slide presentations that are delivered by FDA employees to external audiences at events sponsored by, or co-sponsored by, the agency.
Meetings Sponsored by FDA:  Meetings, Conferences, & Workshops
Events Co-sponsored by FDA (must determine where this information will be housed)

Action Item 7: FDA will compile all FDA Center guidance and standard operating procedures on FDA employees meeting with sponsors about product applications on the web-based resource, FDA Basics for Industry.
Link: Product Application and Petition Review Process

Action Item 8: FDA will describe the types of notifications it provides to industry (e.g., letter acknowledging receipt of the application, mid-cycle review meetings) associated with the product application review process. FDA will explain its practice of providing the sponsor with the name and contact information of the individual who should be contacted with questions about the product application. FDA will provide an overview of the processes used to strive for consistency of product application review.
Link: FDA Basics for Industry

Action Item 11:  FDA will form a cross-Agency working group to identify the best practices for improving the transparency and efficiency of its guidance development processes, and prepare a report with its findings.
Link: Report on Good Guidance Practices

Action Item 12: FDA will describe ways in which interested individuals can provide input to the agency about guidance development, as part of FDA Basics for Industry
Link: FDA Basics for Industry: Guidances
Link: FDA Basics

Action Item 15:  FDA will publish on the FDA website contact information for each import program manager and update that list annually.  This information is available on FDA Basics for Industry.
Link: Import Program Managers

Action Item 16:  FDA will allow interested members of the public to receive e-mail notifications when an Import Alert is posted on the FDA Web site, or an existing Import Alert is updated. Click to subscribe


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