US appeals court reaffirms e-cigarettes are not drugs/devices
This article was originally published in SRA
A US appeals court has upheld an earlier decision by a district court that barred the Food and Drug Administration from regulating electronic-cigarettes as drug/device products if they are not associated with any health-related claims1,2.
You may also be interested in...
Sponsors of new and existing medicines in New Zealand will have to update their product labels within specified deadlines to include warning statements about certain allergens.
A draft EU guideline explains how disease registries can be used to supplement evidence in the pre-authorization phase and provide infrastructure for post-authorization evidence generation.
Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.