| Autor: |
Stewart, Jerry, Honig, Peter, AlJuburi, Lina, Autor, Deborah, Berger, Susan, Brady, Patrick, Fitton, Helen, Garner, Carlos, Garvin, Michael, Hukkelhoven, Mathias, Kowalski, Robert, Milligan, Sandra, O'Dowd, Liza, Reilly, Edward, Roberts, Khyati, Robertson, Andrew S., Taisey, Mark, Thakkar, Roopal, Van Baelen, Karin, Wegner, Max |
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| Zdroj: |
Clinical Pharmacology & Therapeutics; Jun2021, Vol. 109 Issue 6, p1390-1392, 3p |
| Abstrakt: |
A global crisis the magnitude of coronavirus disease 2019 (COVID-19) can transform drug development and review. COVID-19: A Catalyst to Accelerate Global Regulatory Transformation Similar to how we take such exceptional action for COVID-19 patients, we need to advance regulatory policy for patients with life-limiting autoimmune conditions, late-stage heart failure, or other serious illnesses. In order to rapidly accelerate the development and manufacturing scale-up of COVID-19 treatments and vaccines, regulators have employed risk-based decisions to defer certain CMC requirements to later stages of development or even post approval. [Extracted from the article] |
| Databáze: |
Complementary Index |
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