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U.S. Department of Health and Human Services

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Reasoning: Action 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.

Reasoning:

Providing members of regulated industry access to information about agency policies and procedures presented at meetings to external audiences may lead to a more efficient regulatory process.  Industry may be provided information that informs product submissions, leading to a smoother application review process.  Information provided at these meetings may also inform a company’s compliance efforts, contributing to FDA’s efforts to protect the public health.

As suggested by the comments the Task Force received on this issue, one of the most direct means of expanding access to regulatory information presented by FDA employees to external audiences is by posting that information on the FDA Web site.  The Task Force concluded that FDA should expand access to slide presentations delivered by FDA employees to external audiences.  Providing access to all FDA presentations delivered to external audiences on the FDA Web site, however, requires making the presentations 508 compliant before posting the presentations online.

As a first step, FDA will post slide presentations delivered by FDA employees to external audiences at events sponsored by, or co-sponsored by FDA.  FDA is also proposing to list presentations given by FDA employees to external audiences on the FDA Web site (see Draft Proposal 1 below).  The Task Force believes that this list can be used by industry members to request presentations of interest.

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