WASHINGTON, March 4 -- Food and Drug Administration has issued a notice called: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request.
The notice was published in the Federal Register on March 4 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Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers." This draft guidance is intended to assist applicant...