US-FDA TRANSITION PLAN FOR MEDICAL DEVICE UNDER EUA IN USA
On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.
US-FDA Announces New Requirements to Facilitate Export of Food Under China New Registration – Decree 248
On December 6, 2021 the FDA announced that establishments currently exporting certain food products to China to voluntarily submit information. The FDA is implementing this request in response to new facility registration requirements from China.
Registration of Biologics in Brazil
Trying to register your biologic in Brazil? Read GRP’s blog to get a greater understand of the regulations, pathways and timelines.