Animal Models-Essential Elements To Address Efficacy Under the Animal Rule; Notice of Public Meeting; and Reopening of Comment Period

الملخص

The Food and Drug Administration's (FDA or agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing a public meeting to solicit comments and concerns of industry, other government agencies, and interested parties on the regulatory and scientific challenges as addressed in the draft document entitled "Guidance for Industry: Animal Models--Essential Elements to Address Efficacy Under the Animal Rule" dated January 2009 (Draft Guidance), and as related to the development of medical countermeasures under the "Animal Rule" with respect to chemical, biological, radiological, or nuclear (CBRN) threats. Comments on these issues will be considered in connection with the development of a final version of the Draft Guidance.