Blog | Veristat Insightful Perspectives

Regulatory Insights on COVID-19 Updates From FDA | 31 March 2020

FDA UPDATES -  For Sponsors with Products Intended to Treat Indications Other than COVID-19

 

In this unique time, with many health authorities, governments and pharmaceutical companies focused on the global pandemic and how to prevent, diagnose and treat COVID-19, it is important to remember the number of therapies currently in development or already approved for the multitude of other diseases affecting people worldwide.  FDA has issued several press releases and guidance that affect Sponsors running or planning clinical studies, those planning marketing applications and those with products already on the market.  We summarize here valuable information that is important for drug and biologic companies to be aware of as they continue to try to make these therapies available to patients. 

Read More

Covid-19 Update from FDA | Conduct of Clinical Trials During Covid-19 Outbreak

FDA Guidance On Clinical Trial Conduct During COVID-19 Pandemic -  18 March 2020 

 

Read More