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U.S. Department of Health and Human Services

For Industry

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Glossary

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Abbreviated New Drug Applications (ANDA) – Applications submitted for generic drug products that are comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. The review of ANDAs is not a part of the process for the review of human drug applications as defined in PDUFA.

Annual Reports – A report submitted annually by the applicant within 60 days of the anniversary date of U.S. approval of the application.

Biologics License Applications (BLA) – A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.

Efficacy Supplements – Following approval of an original NDA or BLA, a sponsor may later submit an application to expand the disease indications included in the drug labeling. This application often includes additional clinical study data to support the proposed change in labeling, and is referred to as an Efficacy Supplement. FDA's review of Efficacy Supplements is very similar to the review of original NDAs and BLAs, and results in an action letter to the sponsor outlining FDA's decision.

Investigational New Drug Applications (IND) – An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved new drug application.

Labeling Supplements – The sponsor of an approved drug may submit a labeling supplement for human prescription drugs and biological products to change the pertinent information about the appropriate use of the drugs or biological products.

Manufacturing Supplements – The details of manufacturing are described in the Chemistry and Manufacturing Controls (CMC) section of the NDA. After product approval, sponsors often continue to refine the manufacturing process. They must submit these changes in a manufacturing supplement for FDA review, and await FDA prior approval before implementing more significant changes proposed in CMC supplements.

New Drug Applications (NDA) – When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States.

New Molecular Entity (NME) – A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form.

Prescription Drug User Fee Act (PDUFA) – In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). PDUFA authorized FDA to collect fees from companies that produce certain human drug and biological products. Any time a company wants the FDA to approve a new drug or biologic prior to marketing it must submit an application along with a fee to support the review process. In addition, companies pay annual fees for each manufacturing establishment and for each prescription drug product marketed. (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm118833.htm)

Special Protocol Assessments (SPA) – The FDA reviews the SPAs submitted by sponsors to assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsors. Three types of protocols related to PDUFA products are eligible for this special protocol assessment under the PDUFA goals: Animal Carcinogenicity protocols; Final Product Stability protocols; and Clinical protocols.

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