Procedures for Issuance of and Review and Response to Materials Submitted in Response to Clinical Hold for Investigational New Drug (IND) Applications; Availability

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The Food and Drug Administration (FDA) is announcing the availability of two documents entitled ``Centerwide Policy on Issuance of and Response to Clinical Hold Letters for Investigational New Drug Applications'' (OD-R-8-96, Center for Biologics Evaluation and Research (CBER)) and ``IND Process and Review Procedures'' (MAPP 6030.1, Center for Drug Evaluation and Research (CDER)). The documents specify the procedures for the issuance of and review and response to material submitted in response to a notice of clinical hold. It is intended that these documents will clarify the agency's policy in regard to responses to clinical holds. The documents are made available as part of the agency's commitment to review and respond to data submitted in response to a clinical hold within 30 days of receiving the submission, as stated in the November 1995, Presidential National Performance Review report entitled ``Reinventing the Regulation of Drugs Made from Biotechnology.''