WASHINGTON, July 14 -- Food and Drug Administration has issued a notice called: Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.
The notice was published in the Federal Register on July 14 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 titled "Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs." This guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the-counter (OTC) monograph drugs or organizations nominated by sponsors or requesto...