FDA Expedited Program for serious conditions – Priority Review Designation

Published by IRDiRC

Accelerated Aproval Early Access Support Regulatory Advice Regulatory Affairs

FDA-AA is designed to support the development of drugs that treats serious or life- threatening conditions AND generally provides a meaningful advantage over available

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Published by IRDiRC

Biologics License Application Marketing Authorisation New Drug Application Priority Review Designation Priority Review Voucher Regulatory Advice Regulatory Affairs

A Priority Review designation results in an abbreviated PDUFA mandated goal date for a Biologics License Application (BLA) or a New Drug Application (NDA), from 10 months (under standard procedure) to 6 months.

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FDA Milestones meetings – Type B

Published by IRDiRC

Early Access Support End of Phase 2 Meeting Milestone Meeting Pre-NDA Meeting Regulatory Advice Regulatory Affairs Scientific Advice

The default drug development program includes three milestones, or Type B meetings. The earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2) Meeting, and the third milestone is the Pre-NDA Meeting.

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Neglected and Tropical Diseases Priority Review Voucher

Published by IRDiRC

Early Access Support Neglected and Tropical Disease Priority Review Voucher Regulatory Advice Regulatory Affairs Scientific Advice

This program grants a priority review voucher (PRV) from the US Food and Drug Administration (FDA) to sponsors of certain tropical disease product application

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Rare Pediatric Priority Review Voucher

Published by IRDiRC

Marketing Authorisation Orphan Medicine Paediatric Medicine Rare Paediatric Priority Voucher Regulatory Advice Regulatory Affairs Research and Drug Development

This program grants a voucher for priority review from the US Food and Drug Administration (FDA), which aim to render a decision within 6 months (in contrast to 10 for a standard review). The developed drug for which the voucher is awarded must be intended for a rare disease or condition and that primarily affect individuals from 0 to 18 years. The voucher can be utilized for any other drug development program.

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FDA Expedited Program for serious conditions – Special Protocol Assessment

Published by IRDiRC

Clinical Development Clinical Trial Design Regulatory Advice Regulatory Affairs Special Protocol Assessment

FDA-SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies, to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.

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PMDA consultations

Published by IRDiRC

Early Access Support MHLW or PMDA Regulatory Regulatory Advice Regulatory Affairs Scientific Advice

PMDA offers consultations to give guidance and advice on clinical trials of drugs, medical devices, and regenerative medical products as well as on data for regulatory submissions. For designated orphan drugs, PMDA offers Priority consultation.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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