FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: GENERAL CONSIDERATIONS FOR THE USE OF NEW APPROACH METHODOLOGIES IN DRUG DEVELOPMENT; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, March 19 -- Food and Drug Administration has issued a notice called: General Considerations for the Use of New Approach Methodologies in Drug Development; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on March 19 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "General Considerations for the Use of New Approach Methodologies in Drug Development." The purpose of this draft guidance is to provide drug developers with a validation framework and general recommendations for using new approach methodologies (NA...