Simple 2 Test available OTC as first FDA-authorized test with at-home sample collection for any sexually transmitted disease other than HIV.
The US Food and Drug Administration grants marketing authorization for LetsGetChecked's Simple 2 Test, the first FDA-authorized diagnostic test for chlamydia and gonorrhea with at-home sample collection.
Prior to the agency’s authorization on 15 November for LetsGetChecked, the business name for PrivaPath Diagnostics Ltd., the only...
Prominent trade groups call on the European Commission to improve risk assessment of innovative food products by making changes to processes at the European Food Safety Authority.
Along with two instructional videos, FDA provides fact sheet detailing common problems with NDINs while supplement industry awaits guidance on two hurdles for clearing the NDIN process, providing identity information and evidence of safety for ingredients.
Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
