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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
23 October 2020
With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday t...

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23 October 2020
The European Commission (EC) is seeking public consultation on a new preliminary opinion on the potential association between breast implants and a type of lymphoma, with comments due by 7 December 2020.
23 October 2020
In a recently released reflection paper, the European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may ...
23 October 2020
Updated 23 October to include new information on Veklury, Kaletra, Actemra, AZD7442, Remicade and Pepcid (famotidine).
22 October 2020
After a vaccine against COVID-19 is authorized or approved, how will its safety and efficacy be assessed? In addition to ongoing postmarket surveillance requirements, the US Food and Drug Administration (FDA) and the Centers for Disease Control an...
22 October 2020
The US Food and Drug Administration (FDA) has given full approval to the first drug to treat COVID-19. The antiviral Veklury (remdesivir, Gilead Sciences) received approval on 22 October to treat older children and adults who are hospitalized with...
22 October 2020
Erik Hansson, the European Commission’s deputy head of devices, will be among the expert panelists kicking off RAPS’ 2020 Euro Convergence, being held live online, 26–30 October. The 26 October plenary, Global Perspectives on the 2020 Regulatory L...