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Zdrowie i gospodarka · 25.08.2000

Presubmission Conferences

The Food and Drug Administration (FDA) is proposing to amend its new animal drug regulations to describe the procedures to be followed for requesting, conducting, and documenting presubmission conferences. Under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug Availability Act of 1996 (ADAA), any person intending to file a new animal drug application (NADA) or supplemental (NADA) or to investigate a new animal drug is entitled to one or more conferences with FDA to reach an agreement establishing a submission or investigational requirement. This proposed regulation describes how a person would request a presubmission conference and describes the procedures for the conduct of the presubmission conference.

Source: Federal Register — Food and Drug AdministrationOpen original release →