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U.S. Department of Health and Human Services

Drugs

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Industry Meeting Type

FDA Data Element Number.

CDER Data Element Number. C-DRG-00917

Version Number. 002

Data Element Name. Industry Meeting Type

Description. Industry Meeting Type describes the various types of formal industry meetings that occur.

Source. FDA Modernization Act of 1997

Relationship. Industry Meeting Response describes the disposition of the Industry Meeting Type.

FDA Specifications. None.

CDER Specifications. Industry Meeting Type shall consist of an alphanumeric term which has a maximum length restricted to 30 characters, and a corresponding alphanumeric code with a maximum length of 5 characters. (Reference table column_id = meet_type). In addition, there are three main categories of meetings (Types A, B, and C), and these are reflected in the attribute column of the reference table.

FDA Approved Date.

CDER Approved Date. December 14. 1998; May 21, 1999

FDA Revised Date.

CDER Revised Date.

Data Values.

TYPE NAME DEFINITION FDA CODE
A CRITICAL PATH A meeting which is necessary for an otherwise stalled drug development program to proceed (previously referred to as a "special considerations" meeting). CP
A SPECIAL PROTOCOL, MEDICAL Applies only to the medical portion of the review. Under section 119 (a) of the Modernization Act, FDA is to meet with a sponsor or applicant for the purpose of reaching agreement on the design and size of clinical trials intended to form the primary basis of an effectiveness claim if the sponsor or applicant makes a reasonable written request for such a meeting. The special protocol should be submitted to the appropriate division with a cover memo clearly identifying it as a "Special Protocol for Review". FDA will review the special protocol in 45 days and send a written response to the sponsor. If, after review of FDA response, the sponsor decides that a meeting is necessary, the sponsor may submit a written request for a Type A meeting. SPM
A SPECIAL PROTOCOL, PHARM/TOX Applies only to the pharmacology and toxicology portion of the review. Under section 119 (a) of the Modernization Act, FDA is to meet with a sponsor or applicant for the purpose of reaching agreement on the design and size of clinical trials intended to form the primary basis of an effectiveness claim if the sponsor or applicant makes a reasonable written request for such a meeting. The special protocol should be submitted to the appropriate division with a cover memo clearly identifying it as a "Special Protocol for Review". FDA will review the special protocol in 45 days and send a written response to the sponsor. If, after review of FDA response, the sponsor decides that a meeting is necessary, the sponsor may submit a written request for a Type A meeting. SPX
A SPECIAL PROTOCOL, CHEMISTRY Applies only to the chemistry portion of the review. Under section 119 (a) of the Modernization Act, FDA is to meet with a sponsor or applicant for the purpose of reaching agreement on the design and size of clinical trials intended to form the primary basis of an effectiveness claim if the sponsor or applicant makes a reasonable written request for such a meeting. The special protocol should be submitted to the appropriate division with a cover memo clearly identifying it as a "Special Protocol for Review". FDA will review the special protocol in 45 days and send a written response to the sponsor. If, after review of FDA response, the sponsor decides that a meeting is necessary, the sponsor may submit a written request for a Type A meeting. SPC
B PRE-IND Prior to the submission of the initial IND, the sponsor may request a meeting with FDA to review and reach agreement on the design of animal studies needed support human clinical testing. The format of the IND and the scope and design of planned Phase 1 clinical studies may also be discussed (21CFR312.82). P-IND
B END OF PHASE I The sponsor may request a meeting with FDA after completion of early Phase 1 studies (21CFR312 subpart E or 21CFR314 subpart H) to review the Phase 1 data and reach agreement on plans for Phase 2 program (21CFR312.82). EOP1
B END OF PHASE 2/PRE-PHASE 3 The purpose is to review the Phase 2 data to determine whether it is safe to proceed to Phase 3, to evaluate the plans for the Phase 3 program and protocols, and to identify any additional information necessary to support a marketing application for the uses under investigation (21CFR312.47). Additional guidance regarding End of Phase 2 meetings may be found in MAPP _____ . EOP2
B PRE-NDA/SUPPLEMENT The purpose is to acquaint FDA reviewers with the general information to be submitted in the marketing application, discuss appropriate methods for statistical analysis, discuss proposed format for data in the planned marketing application, to identify those studies that the sponsor is relying on as adequate and well-controlled, and to discuss any major unresolved problems (21CFR312.47). Additional guidance regarding pre-NDA meetings may be found in MAPP ______). P-NDA
C OTC MONOGRAPH FEEDBACK Any non-type A or non-type B meeting where feedback on OTC monographs are discussed. 560FB
C 90 DAY 90-days after the submission of an NDA for a new chemical entity or major indication for a marketed drug, the applicant may request a conference with FDA reviewers. The purpose of the conference, which often is a teleconference, is to discuss the general progress and status of the application and to advise applicants of deficiencies that have been identified which have not been previously communicated (21CFR314.102(c)). 90DAY
C ADVERTISING/ PROMOTION Any non-type A or non-type B meeting where advertising or promotion issues are discussed. ADPRO
C BIOPHARM/ BIOEQUIVALENCE Any non-type A or non-type B meeting where biopharmaceutical or bioequivalence issues are discussed. BIOEQ
C CHEMISTRY Any non-type A or non-type B meeting where chemistry issues are discussed. Specifically excluded are END-OF-PHASE 2/PRE-PHASE 3, PRE-IND, AND PRE-NDA MEETINGS. CMC
C COMPLIANCE Any non-type A or non-type B meeting where compliance issues are discussed. COMPL
C ELECTRONIC SUBMISSION Any non-type A or non-type B meeting where electronic media submitted in support of an application is discussed, regardless of whether it is referring to methods or results. ELECT
C END OF REVIEW CONFERENCE After FDA has concluded the review of an application and issued an approvable or not approvable letter, the applicant may request a meeting with FDA reviewers to discuss what further steps need to be taken by the applicant before the application can be approved (21CFR314.102(d)). EOR
C FILING CONFERENCE If FDA refuses to file an application, the applicant may request in writing, within 30 days of the date of the agency's notification, an informal conference with the agency about whether the agency should file the application. If following the informal conference, the applicant requests that FDA file the application (with or without amendments to correct deficiencies), the agency will file the application over protest (21 CFR 314.101). FC
C GUIDANCE Any non-type A or non-type B meeting where guidance is discussed. An example of a guidance meeting is an endpoints meeting. GUID
C LABELING Any non-type A or non-type B meeting where labeling issues are discussed. LABEL
C OTHER Any non-type A or non-type B meeting that does not fit into a pre-defined type C category. OTHER
C PHASE 4 Any non-type A or non-type B meeting where Phase 4 issues are discussed. PH_4
C PHARM/TOX Any non-type A or non-type B meeting where pharmacology and toxicology issues are discussed. PHTOX
C SAFETY ISSUES Any meeting other than a critical path meeting where safety issues are discussed. SAFTY