What is FDA Type 2 meeting?

What is FDA Type 2 meeting?

A BPD Type 2 meeting is a meeting to discuss a specific issue (e.g., proposed study design or endpoints) or questions where the FDA will provide targeted advice regarding an ongoing BPD program. This meeting type can include substantive review of summary data, but does not include review of full study reports.

What is a Type B meeting with FDA?

Type B meetings, which are routine meetings occurring at pre-defined endpoints between FDA and a sponsor. Meetings typically occur right after or right before the submission of clinical data or a new drug filing.

What is an FDA Type C meeting?

A 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.

What are the types of FDA meetings?

There are 5 different meeting types that can take place between the FDA and sponsors or applicants related to the development of biosimilar or interchangeable products: Biosimilar Initial Advisory (BIA) Meeting. Biosimilar Biological Product Development (BDP) Type 1 Meeting. BDP Type 2 Meeting. BDP Type 3 Meeting. BDP Type 4 Meeting.

What is a type B FDA meeting?

Type B meetings, which are routine meetings occurring at pre-defined endpoints between FDA and a sponsor. Meetings typically occur right after or right before the submission of clinical data or a new drug filing.

What is a Type C meeting?

Type C meetings are basically a “catch all” category and includes any meeting concerning the development and review of a product that does not fall within the scope of Types A or B. FDA notes that it will attempt to schedule all Type C meetings within 75 days of receiving the written meeting request.

What are FDA guidance documents?

Guidance Documents are published by the FDA on a regular basis. They are a methodology they use to communicate information about FDA processes and regulatory requirements. These publications do not have any legally binding status. They just are a way for the FDA to let you know what their current thinking is on…