Search Results for keywords:"Federal Food, Drug, and Cosmetic Act"

The Food and Drug Administration (FDA) announced the user fee rates for fiscal year 2025 under the Over-the-Counter (OTC) Monograph Drug User Fee Program. This program allows the FDA to collect fees from manufacturers of OTC monograph drugs, which do not require a new drug application. For FY 2025, the fee for facilities manufacturing these drugs is set at $37,556 for monograph drug facilities and $25,037 for contract manufacturing organizations. These fees help the FDA cover the costs associated with regulating OTC monograph drugs.

The Food and Drug Administration (FDA) has issued an order permanently banning John Warrington Kosolcharoen from working with companies that have approved or pending drug product applications. This decision resulted from his felony conviction for fraudulently selling an unapproved stem cell product, ReGen, and making misleading claims about its safety and effectiveness. Mr. Kosolcharoen was given the chance to challenge the debarment but did not respond in the provided timeframe, leading to a waiver of his right to a hearing on the decision. During his debarment, any business that employs him for related services could also face penalties.

The Food and Drug Administration (FDA) issued an order banning Jonathan Corbett Cosie from importing any drugs into the United States for 10 years. This decision follows his conviction for two federal felonies related to selling misbranded, unapproved drugs, including some that were falsely labeled and sold without a prescription. Mr. Cosie was notified of his debarment and given the opportunity to request a hearing, but he did not respond, waiving his right to contest the decision. The ban is effective as of March 13, 2025.