FDA Expedited Program for serious conditions – Fast Track Designation

Published by IRDiRC

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

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

View this resource Bookmark this resource

FDA Expedited Program for serious conditions – Breakthrough Therapy Designation

Published by IRDiRC

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

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).

View this resource Bookmark this resource

FDA Expedited Program for serious conditions – Priority Review Designation

Published by IRDiRC

Regulatory Affairs Early Access Support Regulatory Advice Accelerated Aproval

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

View this resource Bookmark this resource

EMA small-medium enterprises (SME) office

Published by IRDiRC

Regulatory Affairs Early Access Support SME Office SME Financial Asssitance Regulatory Assistance Administrative Assistance

The EMA’s SME office promote innovation and the development of new medicines for human and veterinary by offering financial, administrative and regulatory assistance to micro, small and medium-sized pharmaceutical companies.

View this resource Bookmark this resource

Target Patient Value Profile

Published by IRDiRC

Research and Drug Development Target Patient Value Profile Drug Description Patient-Centric Information

A document outlining the goals, profile and potential benefit of a specific product, addressing relevant current and future patient needs in a differentiated way. It provides accurate, up-to-date information describing the expected benefit for patients and describe the drug.

View this resource Bookmark this resource

TREAT-NMD Advisory Committee for Therapeutics

Published by IRDiRC

Advisory Committee for Therapeutics TREAT-NMD

Established in 2009, the TREAT-NMD Advisory Committee for Therapeutics (TACT) is a unique multi-disciplinary international group of internationally recognized academic and industry drug development experts as well as representatives of patient foundations and regulatory experts

View this resource Bookmark this resource

Business Pipeline Meetings

Published by IRDiRC

Regulatory Affairs Early Access Support Scientific Advice Business Pipeline Meeting Budgeting Scientific Expertise

The business pipeline activity is a tool for accurate budgeting and identification of the most appropriate resources and scientific expertise.

View this resource Bookmark this resource

EMA Initiative for Patient Registries

Published by IRDiRC

Regulatory Affairs Patient Data Early Access Support Patient Registry Scientific Advice

Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time. Patient registries can play an important role in monitoring the Safety of medicines

View this resource Bookmark this resource

Joint EMA-FDA Scientific Advice

Published by IRDiRC

Regulatory Affairs Early Access Support Scientific Advice Joint EMA-FDA Scientific 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).

View this resource Bookmark this resource

PMDA consultations

Published by IRDiRC

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

View this resource Bookmark this resource

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience. See our Cookie Policy

Necessary

Always Enabled

Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.

Cookie	Duration	Description
Bookmark Cookie	12 months	This cookie saves your bookmarked resources to your local browser for future use.
Cookie Policy	11 months	The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.

Analytics

IMT Feedback

Did the IMT help you in finding the resource you needed?