FDA partners with European agency for coronavirus vaccine development

Mar 24, 2020 - 03:55 PM
FDA-update-900x400

FDA said it is partnering with the European Medicines Agency (EMA) on regulatory strategies to facilitate the development of COVID-19 vaccines.

During a March 18 meeting, regulators discussed necessary preclinical data and the need to evaluate theoretical risk for vaccine-induced disease enhancement, while acknowledging the urgency of proceeding to human clinical trials with SARS-CoV-2 candidate vaccines

Related News Articles

Headline
AHA responds to FDA request for information on AI-enabled medical devices
The AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of…
Headline
Permanent recall issued for Baxter ventilation system
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
Headline
CDC data shows rise in flu, COVID-19 cases across states 
Flu cases are growing or likely growing in 39 states, according to the latest Centers for Disease Control and Prevention data from Nov. 11. COVID-19…
Headline
Recall issued for mislabeled potassium chloride
The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled…
Headline
Study finds flu, COVID-19 infection temporarily raises risk of heart attack, stroke 
A study published Oct. 30 by the American Heart Association found that people have an elevated risk of heart attack and stroke following flu and COVID-19…
Headline
CDC adopts ACIP recommendations for COVID-19, chickenpox vaccines
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations…