2019 - Understanding FDAs Governance of Prescription Drug Development: Manufacturing/cGMPs, Submission Process and Post Approval Commitments - Part 2

This webinar will talk focus on:
Important considerations that matter during prescription drug development process including: API characteristics, Drug Formulation Properties, Dose, Strength and Presentation, Analytical Characterization, Technology Transfer and Target Product Profile
What are some of the tradeoffs that must be made to obtain a stable product formulation?
Why does technology not always scale easily?
What are cGMPS and why do they matter so much
How is all the information developed during product development collected and organized into a submission to FDA
How long does it take for FDA to review my application and should I expect a first pass approval?
Now that FDA has approved my application, why do I have to make post-approval commitments
What are the consequences of not living up to post-approval commitments