FDA action has harmed business, says Utah
This article was originally published in Clinica
Utah Medical is feeling the impact of the recent blow dealt by the US FDA when the agency announced its intention to seek a permanent injunction against the company from selling medical devices. The decision, considered to be a particularly aggressive move by the FDA, was the latest twist in the ongoing dispute between the agency and Utah, in which the FDA claims that the company's production facility does not conform to certain federal manufacturing standards (see Clinica No 1120, p 11).
You may also be interested in...
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA neuroscientist Andrew Shen.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.