EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age

As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The parallel scientific advice program shared by the European Medicines Agency (EMA) and the...

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Autores principales: Thor, Shannon, Vetter, Thorsten, Marcal, Anabela, Kweder, Sandra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2023
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9985489/
https://www.ncbi.nlm.nih.gov/pubmed/36871110
http://dx.doi.org/10.1007/s43441-023-00501-9
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author Thor, Shannon
Vetter, Thorsten
Marcal, Anabela
Kweder, Sandra
author_facet Thor, Shannon
Vetter, Thorsten
Marcal, Anabela
Kweder, Sandra
author_sort Thor, Shannon
collection PubMed
description As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The parallel scientific advice program shared by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) provides a mechanism for experts to concurrently engage in scientific discourse with sponsors on key issues during the development phase of new medicinal products (drugs, biologicals, vaccines, and advanced therapies).
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spelling pubmed-99854892023-03-06 EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age Thor, Shannon Vetter, Thorsten Marcal, Anabela Kweder, Sandra Ther Innov Regul Sci Original Research As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The parallel scientific advice program shared by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) provides a mechanism for experts to concurrently engage in scientific discourse with sponsors on key issues during the development phase of new medicinal products (drugs, biologicals, vaccines, and advanced therapies). Springer International Publishing 2023-03-04 2023 /pmc/articles/PMC9985489/ /pubmed/36871110 http://dx.doi.org/10.1007/s43441-023-00501-9 Text en © This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Research
Thor, Shannon
Vetter, Thorsten
Marcal, Anabela
Kweder, Sandra
EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
title EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
title_full EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
title_fullStr EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
title_full_unstemmed EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
title_short EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
title_sort ema-fda parallel scientific advice: optimizing development of medicines in the global age
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9985489/
https://www.ncbi.nlm.nih.gov/pubmed/36871110
http://dx.doi.org/10.1007/s43441-023-00501-9
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