Zdrowie i gospodarka · 29.06.2016

Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in Food and Drug Administration Advisory Committees; Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Guidance for the Public, FDA Advisory Committee Members, and FDA Staff." This draft guidance addresses FDA's process, under Government-wide Federal regulations, for evaluating whether an advisory committee member has an appearance issue that raises concerns about the member's participation in an advisory committee meeting and describes FDA's process for determining whether to authorize a member with an appearance issue to participate in the advisory committee meeting. This draft guidance is not final nor is it in effect at this time. FDA is also requesting comment on whether FDA should request that each advisory committee member who has an appearance issue and who has received an authorization from FDA to participate in an advisory committee meeting voluntarily publicly disclose the authorization.