Abstract
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.
MeSH terms
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Antibodies, Monoclonal / therapeutic use
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Biological Products / therapeutic use*
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COVID-19 Drug Treatment
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Cell- and Tissue-Based Therapy
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Drug Approval
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Humans
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Immunoconjugates / therapeutic use
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Internationality
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Rare Diseases / drug therapy
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United States
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United States Food and Drug Administration
Substances
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Antibodies, Monoclonal
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Biological Products
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Immunoconjugates