COVID-19 Vaccines: Global Regulators Define Preclinical Data Requirements
Address Thorny Issue Of Studying Vaccine-Induced Disease Enhancement
Regulators held a virtual meeting to agree on the type and extent of preclinical data needed to inform the clinical development of vaccines for COVID-19.
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Regulators are trying to keep sight of the bigger picture amidst disparate efforts to develop potential treatments and vaccines for the coronavirus outbreak. The World Health Organization and EU regulators are concerned that small individual studies may not be in the best interests of patients and are suggesting pooling resources.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-nine guidance documents have been posted on the tracker since its last update.
A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule.