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Recorded Webinar
FDA requirements for Risk Evaluation and Management Strategies: new laws and recent changes to the FDA approach
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
The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers of all drugs to ensure that the benefits of a drug or biological product outweigh its risks. This authority allows the FDA to require different risk control mechanisms including education programs, pre-testing and controlled distribution to reduce the medication risk to patients and ensure appropriate use. This authority extends to all new and marketed products. However, this year saw a substantial change by FDA in the types of REMS that they require for products marketed in the USA
This webinar will teach you:
- FDA Regulations for for REMS in the USA
- Recent changes by the FDA in the REMS requirements
- REMS programs that have been approved by the FDA
- How to develop and validate a REMS program to gain approval by the FDA
Who should attend
Anyone who is interested in learning more on FDA requirements for Risk Evaluation and Management Strategies.
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