FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: LIST OF BULK DRUG SUBSTANCES FOR WHICH THERE IS A CLINICAL NEED UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT; EXTENSION OF COMMENT PERIOD

WASHINGTON, June 26 -- Food and Drug Administration has issued a notice called: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period.

The notice was published in the Federal Register on June 26 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act" that appeared in the Federal Registerof May 1, 2026. In the Federal Registernotice, FDA requested comments on FD...