§379j–41 Definitions

Summary

Defines key words used in this part so people know how they apply. “Abbreviated new drug application” means an application filed under section 355(j), the old section 357 as it stood before November 21, 1997, or under rules in place before the 1984 Drug Price Competition and Patent Term Restoration Act, but it does not include applications for positron emission tomography drugs or applications filed by State or Federal governments for drugs not sold commercially. “Active pharmaceutical ingredient” means the drug substance that gives the medicine its effect, or a substance that must be further purified or combined to become that drug substance. “Adjustment factor” means the Consumer Price Index for all urban consumers (all items; U.S. city average) for October of the prior fiscal year divided by that Index for October 2011. “Affiliate” means a business that controls, is controlled by, or is under common control with another business. “Contract manufacturing organization facility” means a place that makes a finished drug under an abbreviated new drug application but is not named in the approved application held by the facility owner or its affiliate. “Facility” means a single business under one management at one location that makes or processes an active ingredient or a finished dosage form, but not a place that only repackages, relabels, or tests; nearby buildings can count as one location if they are part of the same enterprise, under the same local managers, and can be inspected in one FDA visit, and a place with different management counts as multiple facilities. “Finished dosage form” means the drug as given to a patient (for example, a tablet, capsule, solution, topical), forms that must be reconstituted before use (like some powders), or an active ingredient combined with other parts to make those products. “Generic drug submission” means an abbreviated new drug application, an amendment to one, or a prior approval supplement. “Human generic drug activities” covers FDA work on generic drugs: reviewing submissions and drug master files; issuing approval or complete response letters; issuing letters about Type II active ingredient master files; inspections; monitoring related research; postmarket safety work (collecting and analyzing adverse events, improving IT and analytics, and carrying out postapproval studies, REMS, and adverse-event reporting requirements); and related regulatory science. “Positron emission tomography drug” means the same as “compounded positron emission tomography drug” in another part of the law, except for one specific subparagraph that does not apply. “Prior approval supplement” means a request asking the FDA to OK a change that could substantially affect the drug’s identity, strength, quality, purity, or potency. “Resources allocated for human generic drug activities” means the money spent on FDA staff and contractors, information management and computer systems, facilities and equipment, and the costs of collecting fees and accounting for these review and inspection activities. “Type II active pharmaceutical ingredient drug master file” means a submission to FDA that lets the agency reference confidential information to support a generic drug approval without the submitter having to give that information to the generic applicant.