Regulatory response to the COVID-19 pandemic

Regulatory response to the COVID-19 pandemic: Fast tracking therapeutics

The efforts to end the COVID-19 pandemic have been multifaceted: epidemiological data for understanding, vaccines and non-pharmaceutical interventions for prevention, and new or repurposed drugs for treatment.  In this blog post, Monia Tumminello, Manager, Cortellis Regulatory Intelligence™, and Jaime Polychrones, Medical Writer, Cortellis Regulatory Intelligence, discuss the regulatory response to therapeutic development, from issuing new […]

Regulatory response to the COVID-19 pandemic: Prevention via non-pharmaceutical intervention

Preventive strategies for COVID-19 include a variety of non-pharmaceutical interventions (NPIs) such as social distancing and the use of personal protective equipment (PPE). Reliable case identification and contact tracing guide the distribution of supplies and implementation of NPIs. In this blog post, we discuss how regulatory agencies have addressed the ongoing need for NPI, PPE, […]

Regulatory response to the COVID-19 pandemic: Careful planning to minimize disruptions

Beyond the need to address the ongoing pandemic itself, regulators also must address the impacts to clinical trials as well as essential supplies of treatments and medicines for other diseases and conditions. In this final blog post of our series, we describe strategies to minimize disruption to ongoing clinical trials, drug manufacturing and essential supplies […]