ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations

The regulatory approval of COVID-19 vaccines towards the end of 2020 and start of 2021 coincided with the detection of new SARS-CoV2 strains in the UK, South Africa and Brazil. The ACCESS consortium has released a document detailing the regulatory approach for updating authorised coronavirus vaccines to target new strains. Read more “ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations”

EC proposes “HERA Incubator” initiative to pre-empt the threat of COVID-19 variants

The European Commission (EC) has proposed an action plan called the “HERA Incubator” to shape the European Union’s (EU’s) strategy for combating the threat of future COVID-19 variants. The initiative is modelled on the annual influenza vaccine programme. Read more “EC proposes “HERA Incubator” initiative to pre-empt the threat of COVID-19 variants”

MHRA provides guidance on managing COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials

The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance document on managing clinical trials during COVID-19 with a new section pertaining to the management of non-COVID-19 trials in the context of the current COVID-19 vaccination programme. Read more “MHRA provides guidance on managing COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials”

FDA publish guidance on bioequivalence studies that have been impacted by COVID-19

Acknowledging the disruption to bioequivalence studies intended for submission in Abbreviated New Drug Applications (ANDAs) caused by the COVID-19 pandemic, the US Food and Drug Administration (FDA) has provided details on how sponsors should manage the situation. Read more “FDA publish guidance on bioequivalence studies that have been impacted by COVID-19”

US FDA exempt certain medical devices from premarket notification requirements as part of their COVID-19 response

With the unprecedented COVID-19 public health emergency leading to an unforeseen demand for certain medical devices, the US Food and Drug Administration (FDA) has published a notice exempting these devices from 510(k) premarket review requirements. Read more “US FDA exempt certain medical devices from premarket notification requirements as part of their COVID-19 response”