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U.S. Department of Health and Human Services

For Industry

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GDUFA Glossary

 

Closing out a request for a first cycle review teleconference
Cohort
Complete response letter
Complete review
Controlled correspondence
Drug Master File or Type II Active Pharmaceutical Ingredient Drug Master File
Electronic
Expedited review of application
Facility
Finished Dosage Form
First major deficiency application
Generic Drug Program
Major and minor amendments
Parity
Refuse to receive
Solicited amendment
Submission date
Tentative approval letter for an ANDA
Type II Active Pharmaceutical Ingredient Drug Master File or Drug Master File
Unsolicited amendment
 
Act on an application - FDA will either issue a complete response letter, an approval letter, a tentative approval letter for an ANDA, or a refuse to receive action.
 
Active pharmaceutical ingredient --
  • (A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended to be used as a component of a drug and intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or
  • (B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become the final active pharmaceutical ingredient as defined in paragraph (A).
Approval letter - A written communication to an applicant from FDA approving an application or an abbreviated application 
 
Backlog – the queue of pending ANDAs, ANDA amendments and ANDA supplements pending as of October 1, 2012.
 
Closing out a request for a first cycle review teleconference -
  • 1) holding the teleconference; or
  • 2) responding to questions in the sponsor’s teleconference request in writing in lieu of holding the teleconference.
 
Cohort – The program is structured based on 5 cohorts of submission dates (original ANDAs, PASs and DMFs), corresponding to the five fiscal years to be covered by the program. The year 1 cohort refers to the dates of submissions made electronically in FY 2013 (October 1, 2012 to September 30, 2013). The year 2 cohort refers to the dates of submissions made electronically in FY 2014 (October 1, 2013 to September 30, 2014). The year 3 cohort refers to the dates of submissions made electronically in FY 2015 (October 1, 2014 to September 30, 2015). The year 4 cohort refers to submissions made electronically in FY 2016 (October 1, 2015 to September 30, 2016). The year 5 cohort refers to submissions made electronically in FY 2017 (October 1, 2016 to September 30, 2017).
 
Complete response letter - a written communication to an applicant or DMF holder from FDA usually describing all of the deficiencies that the agency has identified in an abbreviated application (including pending amendments) or a DMF that must be satisfactorily addressed before the ANDA can be approved. Complete response letters will reflect a complete review and will require a complete response from industry to restart the clock. Refer to 21 CFR 314.110 and http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084138.htm  for additional details. When a citizen petition may impact the approvability of the ANDA, FDA will strive to address, where possible, valid issues raised in a relevant citizen petition in the complete response letter. If a citizen petition raises an issue that would delay only part of a complete response, a response that addresses all other issues will be considered a complete response.
 
Complete review – a full division-level review from all relevant review disciplines, including inspections, and includes other matters relating to the ANDA and associated DMFs as well as consults with other agency components.).
 
Controlled correspondence - FDA’S Office of Generic Drugs provides assistance to pharmaceutical firms and related industry regarding a variety of questions posed as "controlled documents." See http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm120610.htm. Controlled correspondence does not include citizen petitions, petitions for reconsideration or requests for stay.
 
Delaying amendments – amendments to an ANDA from the ANDA sponsor to address actions by a third party that would cause delay or impede application review or approval timing and that were not or may not have been initially recognized by FDA as necessary when the application was first submitted. FDA’s Office of Generic Drugs shall have broad discretion to determine what constitutes a delaying event caused by actions generally outside of the applicants control taking into account facts and information supplied by the ANDA sponsor.
 
Drug Master File or Type II Active Pharmaceutical Ingredient Drug Master File -- a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.
 
Electronic– submissions in an all electronic eCTD format in effect at the date of submission.
 
Expedited review of application – While generally, review of original ANDAs, ANDA amendments and ANDA supplements are reviewed in the order received, (first-in, first-reviewed), certain applications may be identified at the date of submission for expedited review, as described in CDER’s MAPP 5240.3. (See
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm079787.pdf) which includes expedited review of the orginial submission and amendment(s) associated with the expedited review qualifying application. Products to respond to current and anticipated public health emergencies, products under special review programs, such as the President’s Emergency Plan for AIDS Relief (PEPFAR), products for which a nationwide shortage has been identified, and first generic products for which there are no blocking patents or exclusivities on the reference listed drug currently may qualify for expedited review. For ANDAs in the year 1 and 2 cohorts, FDA will expedite review of Paragraph IV applications that are submitted on the first day that any valid Paragraph IV application for the drug in question is submitted.
 
Facility -- business or other entity under one management either direct or indirect and at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form, but does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing. For purposes of this definition, separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are closely related to the same business enterprise, under the supervision of the same local management, and are capable of being inspected by the Food and Drug Administration during a single inspection.
 
Finished Dosage Form
  • (A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application;
  • (B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or
  • (C) any combination of an active pharmaceutical ingredient, as defined in paragraph (m)(2), with another component of a drug product for purposes of production of such a drug product.
 
First major deficiency application - an ANDA which has been issued its first complete response letter classified as having major deficiency(ies).
 
Generic Drug Program – all agency activities related to the determination of approvability of an ANDA.
 
Major and minor amendments – All references to “major” and “minor” amendments in this goals letter are intended to refer to the distinctions that FDA described in its Guidance for Industry: Major, Minor, Telephone Amendments to Abbreviated New Drug Applications. See http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072888.pdf
 
Parity – in reference to inspections, as between foreign and domestic facilities, means inspection at an equal frequency plus or minus 20 percent with comparable depth and rigor of inspection.
 
Prior Approval Supplements -A prior approval supplement is a submission to allow a company to make a change in a product that already has an approved ANDA. CDER must approve all important ANDA changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met. (Source: http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#S)
 
Refuse to receive – refusal to file an application. See 21 CFR 314.101 and
 
Solicited amendment -- an amendment submitted in response to a Complete Response letter.
 
Submission date – is the date an ANDA, ANDA amendment, ANDA supplement, or Type II active pharmaceutical drug master file arrives in the appropriate electronic portal of the FDA.
 
Tentative approval letter for an ANDA - A written communication to an applicant from FDA delaying the approval of an application or an abbreviated application by an effective date.   A tentative approval letter is issued to the applicant if the application is submitted for approval before the expiration of any patents or exclusivities granted to the original, brand-name product. The tentative approval letter delays final approval of the application until all patent or exclusivity issues have been resolved.
 
Type II Active Pharmaceutical Ingredient Drug Master File or Drug Master File -- a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.
 
Unsolicited amendment – an amendment with information not requested by the FDA except for those unsolicited amendments considered routine or administrative in nature and that do not require scientific review (e.g., requests for final ANDA approval, patent amendments, general correspondence, and USP monograph updates).