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Pandemic Best Regulatory Practices: An Urgent Need in the COVID-19 Pandemic.
Lumpkin, Murray M; Lim, John C W.
  • Lumpkin MM; The Bill and Melinda Gates Foundation, Seattle, Washington, USA.
  • Lim JCW; Centre of Regulatory Excellence, Duke-NUS Medical School, Singapore.
Clin Pharmacol Ther ; 108(4): 703-705, 2020 10.
Article in English | MEDLINE | ID: covidwho-526620
ABSTRACT
As large numbers of candidate drugs and vaccines for potential use in the coronavirus disease 2019 (COVID-19) pandemic are being investigated, medicine regulators globally must now make urgent, informed, contextually risk-1based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight "pandemic best regulatory practices." These should support both the regulatory public heath imperative and assure timely patient access to effective, safe, quality products worldwide during this emergency-thus contributing to ending this pandemic as quickly, effectively, and safely as possible.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Practice Guidelines as Topic / Drug and Narcotic Control / Pandemics / Betacoronavirus Type of study: Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Clin Pharmacol Ther Year: 2020 Document Type: Article Affiliation country: Cpt.1932

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Practice Guidelines as Topic / Drug and Narcotic Control / Pandemics / Betacoronavirus Type of study: Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Clin Pharmacol Ther Year: 2020 Document Type: Article Affiliation country: Cpt.1932