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Form FDA 356h is needed by pharmaceutical companies or manufacturers who intend to submit a new drug application (NDA), biologics license application (BLA), or an abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration for the approval of a drug product.
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Form FDA 356h is a form used by the Food and Drug Administration (FDA) to collect information on adverse reactions to medical products.
Healthcare providers, manufacturers, and consumers are required to file form FDA 356h if they become aware of any adverse reactions to medical products.
Form FDA 356h can be filled out online on the FDA's MedWatch website or submitted via fax or mail. It requires information on the patient, the medical product, and the adverse reaction.
The purpose of form FDA 356h is to gather data on adverse reactions to medical products in order to monitor the safety of these products and take appropriate regulatory actions if necessary.
Information such as the patient's demographics, the medical product involved, the adverse reaction, and any other relevant details must be reported on form FDA 356h.
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