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56 pages 1 hour read

Bottle of Lies: The Inside Story of the Generic Drug Boom

Nonfiction | Book | Adult | Published in 2019

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Index of Terms

Abbreviated New Drug Application (“Jacket”)

An Abbreviated New Drug Application or ANDA is a submission to the FDA for the approval of a generic drug. It is colloquially referred to as a “jacket.”

Application Integrity Policy (AIP)

An AIP is a type of punishment imposed by the FDA, typically in the form of increased scrutiny and inspections, on generic pharmaceutical manufacturers who have been found to engage in fraudulent practices or data manipulation. The AIP allows the FDA to freeze the applications of a particular drug company. To resume the review process, the company must take corrective actions and demonstrate compliance with FDA regulations.

ALCOA

ALCOA, an acronym that stands for Attributable, Legible, Contemporaneous, Original, and Accurate, is a set of principles for data integrity in the pharmaceutical industry. This phrase came to prominence in the 1980s, when the FDA started emphasizing the importance of maintaining accurate and reliable records in drug manufacturing.

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