How To Get A Meeting With FDA: Guidance Describes Formal Meetings For Biosimilars
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s fourth biosimilars-related guidance describes the formal meeting process for sponsors with products in development; the process will require extensive requests and information packages.
You may also be interested in...
Complex ANDAs: Early Meetings With FDA Can Generate Bonus Communication
By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.
Complex ANDAs: Early Meetings With FDA Can Generate Bonus Communication
By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.
FDA Making A Generic Case For Continuous Manufacturing
The industry that makes the vast majority of drugs has yet to embrace the new production approach, but FDA hopes that platform standardization will make it more compelling.