FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ALTERNATIVE TOOLS: ASSESSING DRUG MANUFACTURING FACILITIES IDENTIFIED IN PENDING APPLICATIONS; GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Sept. 12 -- Food and Drug Administration has issued a notice called: Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Guidance for Industry; Availability.

The notice was published in the Federal Register on Sept. 12 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications." This guidance provides information to applicants on how FDA intends to use alternative tools to assess drug manufacturing facilities identified in a marke...