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Home » FDA Clarifies Guidance on Submitting Field Alert Reports
FDA Clarifies Guidance on Submitting Field Alert Reports
The FDA added some clarifications in a final guidance for sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on submitting field alert reports (FARs), reminding them that FAR requirements apply to all products under an NDA or ANDA including positron emission tomography drugs, designated medical gases, and combination products containing a drug constituent part.