FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CONSIDERATIONS FOR THE USE OF THE PLAUSIBLE MECHANISM FRAMEWORK TO DEVELOP INDIVIDUALIZED THERAPIES THAT TARGET SPECIFIC GENETIC CONDITIONS WITH KNOWN BIOLOGICAL CAUSE; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, Feb. 25 -- Food and Drug Administration has issued a notice called: Considerations for the Use of the Plausible Mechanism Framework To Develop Individualized Therapies That Target Specific Genetic Conditions With Known Biological Cause; Draft Guidance for Industry; Availability.

The notice was published in the Federal Register on Feb. 25 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 draft document entitled "Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause." The draft guida...