What You Need To Know About Liability Protection For COVID-19 Products
Companies developing medical countermeasures for COVID-19 need to become familiar with divergences in the liability protection offered by different countries with regard to possible safety issues that may arise when products are fast-tracked for public health reasons. By doing so they can adopt a systematic process for prospectively evaluating and managing international risks, say Dan Kracov, Lincoln Tsang and Alexander Roussanov.
You may also be interested in...
As the race to develop COVID-19 vaccines continues, EU member states are ready to financially cover certain of the companies’ risks, but not to change the rules on liability. Transparency proponents are calling for all contracts on vaccine purchases to be made public.
Federal law requiring agencies to weigh and document potential environmental impacts of major regulatory actions does not dictate what happens next. Neither does it provide federal agencies with authorities beyond their statutory purviews, FDA/CDER leadership says.
The European Medicines Agency has reported progress with a collaborative project that involves other regulators in its assessments of COVID-19 products, and with the EU Medicines for All initiative for evaluating products for non-EU markets.