IRDiRC

  1. Showing 51 results for:
  2. IRDiRC
All SubjectsEarly Access Support

EMA Innovation Task Force

Published by IRDiRC

Regulatory AffairsEarly Access SupportScientific AdviceEMA Innovation Task ForceEarly Stage Advice

The ITF is a multidisciplinary EMA group that includes scientific, regulatory and legal competences. It was set up to ensure coordination across the Agency and to provide a forum for early dialogue with applicants on innovative aspects in medicines development. Area of interest: innovative therapeutics and techniques, innovative development methods, borderline products.
From the first request by the applicant, the procedure lasts approximately 8-10 weeks (ITF Secretariats confirms eligibility criteria approx. within 2 weeks; when confirmed, then approx. 2 weeks about experts’ involvement + meeting date after 4-6 weeks).

View this resource Bookmark this resource

FDA Expedited Program for serious conditions – Breakthrough Therapy Designation

Published by IRDiRC

Regulatory AffairsEarly Access SupportRegulatory AdviceExpedited ProgrammeBreakthrough 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

Joint EMA-FDA Scientific Advice

Published by IRDiRC

Regulatory AffairsEarly Access SupportScientific AdviceJoint 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