Glossary of Terms

To help you decode the numerous acronyms and other industry terminology, we’ve assembled the following glossary.

505(b)2

A new drug application containing one or more investigations necessary to approval that were not conducted by the applicant and for which the applicant has no right of reference.

ANDA

Abbreviated New Drug Application

API

Active Pharmaceutical Ingredient

cGMP

Current Good Manufacturing Practices

CPSIA

The Poison Prevention Packaging Act (PPPA) of 1970 established the requirement to use child resistant closures on containers of household chemicals including drugs, and that manufacturers test the closures’ effectiveness. The Consumer Product Safety Improvement Act (CPSIA) of 2008 requires that retailers provide certification that products they sell meet the test requirements of the PPPA.

DEA

U.S. Drug Enforcement Agency

DESI

Drug Efficacy Study Implementation. These are drugs that were approved solely on the basis of their safety prior to 1962. Thereafter, Congress required drugs to be shown to be effective as well. FDA initiated a Drug Efficacy Study Implementation(DESI) to evaluate the effectiveness of those drugs that had been previously approved on safety grounds alone. These drugs, and those identical, related, and similar to them, may continue to be marketed until the administrative proceedings evaluating their effectiveness have been concluded, at which point continued marketing is only permitted if an NDA is approved for such drugs.

eCTD

electronic Common Technical Document. For details on the U.S. FDA application process, visit http://www.fda.gov/cder/regulatory/ersr/ectd.htm.

EDI

Electronic Data Interchange

FDA

Food and Drug Administration

Form 483

FDA Form 483 is referred to as “Notice of Inspectional Observations.”
The 483 is issued by the FDA field investigator after an on-site inspection and lists deficiencies of your quality system. The observations contained in every Form 483 are based on the inspector’s interpretation of the regulations as they relate to your operational GMPquality system.

FTF

Federal Transition Framework

GMP

Good Manufacturing Practice. U.S. FDA Good Manufacturing Practice requirements set forth in the Quality System (QS) regulation are promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act. They require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States.

ICH

International Conference on Harmonisation

IP

Intellectual Property

NDC

National Drug Code

Para. IV

Patent Certification Under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an Abbreviated New Drug Application (ANDA) with the FDA has the exclusive right to market the generic drug for 180 days. To begin the FDA approval process, the generic applicant must: 1) certify in its ANDAthat the patent in question is invalid or is not infringed by the generic product (known as “paragraph IV certification”); and 2) notify the patent holder of the submission of the ANDA. For more information visit http://www.fda.gov/cder/ogd/#paragraph.

QA

Quality Assurance

QbR

Question-based Review

QC

Quality Control

QOS

Quality Overall Summary. The Quality Overall Summary summarizes the main points of the ANDA for the reviewers. It is the “roadmap” of the application.

USP

United States Pharmacopeia. The official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States.