Warning Letter Alleges Sponsor-Investigator Did Not Follow All Expanded Access Requirements

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Warning Letter Alleges Sponsor-Investigator Did Not Follow All Expanded Access Requirements

J.W. Schomisch

June 26, 2024 at 02:54 PM EST

A sponsor-investigator received an FDA Warning Letter for allegedly not following all the requirements for a subject’s expanded access to an investigational product. Dr. Angela Ritter of Gainesville, Georgia, received a June 7 Warning Letter from the FDA Center for Drug Evaluation and Research (CDER) alleging she failed to adhere to the requirements for all expanded access us... Read More

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Warning Letter Alleges Sponsor-Investigator Did Not Follow All Expanded Access Requirements

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