If a manufacturer wants to change the way an existing drug is produced, what application must they submit to the FDA?

To change the way an existing drug is produced, a manufacturer must submit a Prior Approval Supplement (PAS) to the FDA. This application is specifically designed for manufacturers seeking to implement significant changes in the production process of an approved drug. A PAS ensures that the FDA can evaluate the impact of these modifications on the drug's quality, safety, and efficacy before the changes can take place in the commercial production.

The necessity of submitting a PAS is underscored by the regulatory framework that governs pharmaceutical manufacturing, ensuring the integrity and reliability of drug products reach consumers. Such changes could include alterations in the manufacturing facility, production methods, or significant changes in ingredients and formulation, all of which warrant thorough FDA review.

Other options provided are not appropriate for this context. A New Drug Application (NDA) is required for a drug that has not previously been approved, an Abbreviated New Drug Application (ANDA) is for generics looking to demonstrate bioequivalence to a already approved drug, and a Change of Condition Application is not a recognized category in FDA regulations.