Food and Drug Administration Compliance Policy Guides. Guide 7132c.07. Drugs-NDA/IND. Guide 7125.34. Veterinary Drug. Guide 7126.27. Animal Feed.

摘要

The document states the Food and Drug Administration's policy and procedures for the issuance of orders to conduct record reviews for approved new drug products for human and animal use. During the generic drug investigations the agency encountered some problems that could not be addressed with traditional legal tools. One such problem involved situations where omissions, inconsistencies, untrue statements of material facts, or outright fraud were found in records (e.g., biobatch manufacturing records) submitted as part of some ANDAs (for human use). Another problem involved departures from approved manufacturing procedures. In these instances, where only a few applications are implicated, FDA can readily initiate action against specific products found to have been approved on the basis of false or incomplete information, or which are not made in accordance with approved procedures. However, where many applications are implicated, the sheer volume of records which must be reviewed makes it difficult to determine how many products are involved.