Anytime COVID Test marketed home-use test without FDA approval or EUA and promoted it with an FDA logo and a “clinical trial number.” Warning letter says “your presentation conveys the misimpression that the product has been approved, cleared, authorized, endorsed or otherwise evaluated by FDA.”
The latest US firm warned about marketing unapproved home-use COVID-19 tests left little chance it wouldn't get the Food and Drug Administration’s attention.
To begin with, the company's name, Anytime COVID Test LLC, likely would spark regulators' scrutiny. And on top of OTC...
The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.
