FDA Qualification process – Drug Development Tools

Published by IRDiRC

Animal Model Biomarker Center for Drug Evaluation and Research Clinical Development Drug Development Tool Endpoint Qualification Process Regulatory Affairs Research and Drug Development

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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Conditional and Time-limited Authorization of Regenerative Medical Products

Published by IRDiRC

Advanced Therapy Procedure CTARP Marketing Authorisation MHLW or PMDA Regenerative Medical Products PMD Act Regulatory Affairs

A regulatory framework for the approval of regenerative medical products to benefit the patients with unmet medical needs under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)

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FDA Expedited Program for serious conditions – Fast Track Designation

Published by IRDiRC

Early Access Support Expedited Programme Fast Track Designation Rare Disease Regulatory Advice Regulatory Affairs

Process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

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US Orphan Drug Designation

Published by IRDiRC

Early Access Support Orphan Drug Designation Orphan Drug Incentive Regulatory Advice Regulatory Affairs

The ODA is intended to provide incentives for Orphan Drug development and to defray the costs of qualified clinical testing expenses incurred in connection with the development of drugs for rare diseases and conditions.

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Japan Compassionate Use Programs

Published by IRDiRC

Clinical Development Compassionate Use Programme Early Access Support MHLW or PMDA Regulatory Regulatory Affairs

A system for patients with life-threatening conditions without effective a treatment to gain access to unapproved investigational medical products.

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Study Group on Unapproved and Off-label Drugs of High Medical Need

Published by IRDiRC

Early Access Support MHLW or PMDA Regulatory Regulatory Affairs Scientific Advice

The objective of the Study Group is to evaluate medical need, investigate necessary studies for market approval, and request company to develop medicinal products to solve the problem of unapproved drug and off- label use with medical need. Public consultations are conducted to gather requests from public.

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Conditional Early Approval System for Medical Devices

Published by IRDiRC

CEASD Conditional Early Approval System Early Access Support Medical Device MHLW or PMDA Regulatory PMDA Regulatory Affairs

Conditional Early Approval System is a system to put highly useful and effective medical devices for treating serious diseases into practical use as early as possible.

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Conditional Early Approval System for Drugs

Published by IRDiRC

Conditional Early Approval System Early Access Support MHLW or PMDA Regulatory Regulatory Affairs

Conditional Early Approval System is a system to put highly useful and effective drugs for treating serious diseases into practical use as early as possible.

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Product specific- pre approval advisory committee

Published by IRDiRC

Advisory Commitee Approval Advisory Committee Early Access Support Regulatory Affairs Scientific Advice Technical Advice

Advisory committees (AC) provide independent advice and recommendations the US FDA on scientific and technical matters related to the development and evaluation of products regulated by the FDA

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FDA Expedited Program for serious conditions – Breakthrough Therapy Designation

Published by IRDiRC

Breakthrough Therapy Designation Early Access Support Expedited Programme Regulatory Advice Regulatory Affairs

Process designed to facilitate the development and expedite the review of drugs intended to treat a serious condition AND preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

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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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