Towards a better use of scientific advice for developers of advanced therapies
| Autor: | Milton Bonelli, Dolca Rogers, Ana Hidalgo-Simon, Anna Tavridou, Anja Schiel |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Pharmacology
Process management media_common.quotation_subject Authorization advanced therapy medicinal products scientific advice drug development 030226 pharmacology & pharmacy Advice (programming) Product (business) 03 medical and health sciences 0302 clinical medicine Agency (sociology) Original Article Pharmacology (medical) Quality (business) 030212 general & internal medicine Business Advanced Therapy Medicinal Products–Original Articles drug regulation media_common |
| Zdroj: | British Journal of Clinical Pharmacology |
| ISSN: | 1365-2125 0306-5251 |
| DOI: | 10.1111/bcp.14672 |
| Popis: | Scientific advice (SA) is an important tool offered by regulators to help developers generate robust evidence on a medicine's benefits and risks. Drawing on accumulated experience and looking at the SA provided by the European Medicines Agency in 2018 to advanced therapy medicinal products originally developed by public bodies, we discuss most commonly raised issues and the complexity and timings of the questions posed. Earlier and more frequent SA could help advanced therapy medicinal product developers to pre-empt delays at the marketing authorisation stage. Carefully addressing quality and nonclinical issues before entering the pivotal phase of development will clear the path for a smooth clinical development and successful marketing authorisation. |
| Databáze: | OpenAIRE |
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