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Preapproval Information Exchange
(16 Results)

Pre-approval Products: Supporting Payer Needs and the Information...

AMCP webinar that reviewed the current pre-approval support features within and insights from the active Payer community.


Pre- and Post-Approval Dossiers: Making All Evidence Count

AMCP webinar that discussed the current state of payer perceptions regarding dossier timing, quality and use as well as future considerations for improving dossier relevancy and optimization of use.


How can payers cope with the consequences of accelerated approval...

AMCP webinar that discussed the significance of the shifting landscape and the dilemmas of the FDA accelerated approval process.


Comparing Payer and Hospital Decision Maker Pre-Approval Product ...

AMCP webinar that provided insights from registered payer and hospital users of the AMCP eDossier regarding the trend of pre-approval product review and compared the perspectives of both types of decision makers.


How do payers utilize the AMCP eDossier System for pre-approval i...

AMCP webinar that reviewed research and evidence that can support the opportunity to use the AMCP eDossier System as a potential safe harbor mechanism.


Pre-FDA Approval Partnership Forum

Partnership Forum: Industry leaders gather together on September 13-14, 2016 to develope recommendations for biopharmaceutical companies and health care decision makers to more easily communicate information on products awaiting FDA approval.

AMCP Format for Formulary Submissions, Version 4.0: A Guided Tour...

AMCP webinar that provided an overview of key updates to the Format, Version 4.0, including new guidance related to emerging special topic considerations such as biosimilars, specialty drugs, and companion diagnostic tests.