Question

Descibe the different types of FDA regulatory meetings and discuss the different types of meetings that you would request for further clinical development (i.e. Phase III trial) of the Company’s investigational medicinal product.

Answer 1

INTRODUCTION- This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter products) regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance does not apply to abbreviated new drug applications. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference, or videoconference).

Type of meeting :-

There are three types of meetings that occur between sponsors or applicants and FDA staff: Type A, Type B, and Type C. Each meeting type is subject to different procedures, as described below.

A. Type A meeting is a meeting, needed to help an otherwise stalled product development program proceed. Examples of a Type A meeting include:

• Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level.

• Meetings to discuss clinical holds in which a response to hold issues has been submitted, but the FDA and the sponsor or applicant agree that the development is stalled and a new path forward should be discussed.

• Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures as described in the guidance for industry Special Protocol Assessment.

         If sponsors or applicants are considering a request for a Type A meeting, before submitting the request they should contact the review division in either CBER or CDER to discuss the appropriateness of the request. Type A meetings should be scheduled to occur within 30 days of FDA receipt of a written meeting request. If a sponsor or applicant requests a meeting date that is beyond 30 days from the date of the request receipt, we will work with the sponsor or applicant to determine the earliest agreeable date.

B. Type B Meeting

Type B meetings are as follows:

• Pre-investigational new drug application (pre-IND) meetings (21 CFR 312.82)

• Certain end-of-phase 1 meetings (21 CFR 312.82)

• End-of-phase 2 and pre-phase 3 meetings (21 CFR 312.47)

Pre-new drug application/biologics license application meetings (21 CFR 312.47) Type B meetings should be scheduled to occur within 60 days of FDA receipt of the written meeting request. If a sponsor or applicant requests a meeting date that is beyond 60 days from the date of request receipt, we will work with the sponsor or applicant to determine the earliest agreeable date.

C. Type C

Type C meeting is any meeting other than a Type A or Type B meeting between CBER or CDER and a sponsor or applicant regarding the development and review of a product.

                Type C meetings should be scheduled to occur within 75 days of FDA receipt of the written meeting request. If a sponsor or applicant requests a meeting date that is beyond 75 days from the date of the request receipt, we will work with the sponsor or applicant to determine the earliest agreeable date.