Food and Drug Administration. – Federal Register Recent Federal Regulation Documents
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Generic Drug User Fee Rates for Fiscal Year 2023
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2023 rates for GDUFA III fees. These fees are effective on October 1, 2022, and will remain in effect through September 30, 2023.
Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop
The Food and Drug Administration (FDA) is announcing a 1-day public workshop, cosponsored with the American Thyroid Association (ATA), entitled ``Propylthiouracyl (PTU)-Related Liver Toxicity.'' This public workshop is intended to provide a public forum for discussion of the clinical, scientific, and regulatory issues pertaining to PTU- induced hepatitis to seek constructive input from academia, regulatory scientists, and other interested parties on the topic of PTU-induced hepatitis. The input from this public workshop will help the ATA to develop guidelines for the management of hyperthyroidism and help inform FDA about necessary changes to prescription drug labeling for PTU.
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