The following presentation was given March 25, 2022 at Rosalind Franklin University for the Educational Series sponsored by the Office of the Executive Vice President of Research by BioPhia consultants Edwin Moore, PhD and Robin Geller, PhD. It describes an overview of the regulatory processes and considerations for entrepreneurs and startup companies in the medical product space.
The overview presents considerations for the different regulatory paths for medical device, pharmaceutical and biologic products. The presentation covers regulatory pathways and requirements of CDER (drugs), CBER (vaccines, blood, and biologics) CDRH (medical devices) and the Office of Combination Prodcuts.