"Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations"

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations," dated February 2003. The guidance document is intended to provide information to assist FDA staff in creating and implementing effective collaborations consistent with relevant legal, ethical, and policy considerations. FDA and its stakeholders use collaborations to take advantage of and amplify the unique resources possessed by each to address a variety of public health issues. The guidance document enumerates factors that FDA employees should consider, and the procedures they should follow, when planning a leveraged collaboration. This guidance finalizes the draft guidance under the same title dated November 2001 that was announced in the Federal Register on November 13, 2001.