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FDA publishes guidance on ANDA submissions.
FDA has published guidance to assist sponsors preparing to submit abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product. The guidance describes what should be included in an ANDA and highlights serious deficiencies that may cause FDA to refuse to receive an ANDA. A refuse-to-receive decision indicates that FDA has determined that an ANDA is incomplete on its face, usually because of omissions.