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All SubjectsEarly Access SupportScientific Advice

INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice on CBER products)

Published by IRDiRC

Drug Development AdviceEarly Access SupportRegulatory AdviceRegulatory AffairsScientific AdviceTargeted Engagement for Regulatory Advice

Through a CBER Initial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting, sponsors can obtain initial, nonbinding advice from FDA regarding chemistry, manufacturing and controls, pharmacology/Toxicology, and/or clinical aspects of the development program

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Stakeholders interactions – Professional affairs and Community Engagement

Published by IRDiRC

Clinical TrialCommunity EngagementEarly Access SupportEarly Stage InteractionPatient AdviceProfessional AffairsRegulatory AdviceRegulatory AffairsScientific Advice

Interaction of the stakeholders and multilateral education at an early stage of development will facilitate drug development (e.g. ensuring outcome measures for clinical trials are developed that are meaningful for patients, are acceptable to the regulators, and are acceptable to payers)

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

Published by IRDiRC

Early Access SupportMHLW or PMDA RegulatoryRegulatory AffairsScientific 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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JoInternationalEMA-FDA Scientific Advice

Published by IRDiRC

Early Access SupportJoInternationalEMA-FDA Scientific AdviceRegulatory SciencesScientific Advice

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services have a program to provide parallel scientific advice (PSA) to sponsors. The goal of the PSA program is to provide a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and Biologics).

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