Refreshing the biologic pipeline 2020

In the absence of face-to-face meetings, FDA and industry implemented regulatory workarounds to maintain drug and biologics approvals. These could be here to stay.

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Bibliographische Detailangaben
Veröffentlicht in:	Nature biotechnology 2021-02, Vol.39 (2), p.135-143
1. Verfasser:	Hodgson, John
Format:	Artikel
Sprache:	eng
Schlagworte:	Agriculture Antibodies, Monoclonal - therapeutic use Antimitotic agents Antineoplastic agents Bioinformatics Biological products Biological Products - therapeutic use Biomedical and Life Sciences Biomedical Engineering/Biotechnology Biomedicine Biotechnology Biotechnology industry Cell- and Tissue-Based Therapy COVID-19 - drug therapy Drug Approval Humans Immunoconjugates - therapeutic use Internationality Licensing, certification and accreditation Life Sciences News Feature Product development Rare Diseases - drug therapy United States United States Food and Drug Administration
Online-Zugang:	Volltext
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Beschreibung
Zusammenfassung:	In the absence of face-to-face meetings, FDA and industry implemented regulatory workarounds to maintain drug and biologics approvals. These could be here to stay.
ISSN:	1087-0156 1546-1696
DOI:	10.1038/s41587-021-00814-w