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

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.”

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, 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.