All U.S. Food and Drug Administration articles
-
News BriefFDA bans Red No. 3 dye after decades of concerns over possible health risks
The U.S. Food and Drug Administration announced Wednesday it has revoked authorization for color additive Red No. 3 from food, beverages, and drugs. Health concerns over dye have existed since it was banned from cosmetics in 1990 after it was found that large doses led to the development of cancer ...
-
News BriefSEC levies no fine against Kiromic BioPharma after material omissions self-disclosure
Kiromic BioPharma will pay no fine to the Securities and Exchange Commission after self-reporting that it failed to disclose material information about two cancer drugs to investors.
-
ArticleCompliance takeaways from FDA’s final ‘intended use’ rule
The U.S. Food and Drug Administration’s “intended use” final rule reaffirms the agency’s wide latitude of discretion in establishing an off-label use case against pharmaceutical and medical device companies.
-
ArticleCOVID-19 vaccine mandates no less tricky after FDA approval
Determining the best way to get your employees vaccinated against COVID-19 means considering a handful of key issues, in addition to being prepared for difficult conversations.