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Recorded Webinar
FDA Approvals and Insights: Understanding US-FDA Drug Regulatory Framework & comparing & contrasting with the complex EU system
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Hoss will provide unique insights into the US development, approval and post-approval processes of drugs (medicines) which should prove valuable for any company.
There are many aspects to the US drug development and approval system including the role of the FDA, the National Institute of Health (NIH), the Advisory Committee, Citizen Petition etc. This is will be clarified. The process for generics, New Molecular Entities, Advanced therapy biologics, new therapeutic proteins, biosimilars, devices and others will be described. Also, tips for FDA meetings and other strategic engagements will be presented.
Also, the presenter is based in Germany and has also lived in France and the UK and has experience with the European MRP, DCP and CP submissions.
In the presentation some aspects addressed will be:
- Organisation and cooperation across different Centers, Offices and divisions
- Small molecules approved under FD&C Act and Biologics under PHS Act.
- Special procedures as “Fast-tracking” or “Accelerated”
- Drug master files
- Post approval changes
- FDA Meetings End of Phase I / II (EOP1 / EOP2a PoC/EOP2b)
- NDA/505(b)(1), Paper NDA/505(b)(2), ANDA/ 505(j). New ABLA under BPCI Act
- Generic Drugs User Fee Amendments GDUFA 2012
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