The company’s marketing application was not properly assessed, says FDA.Read More
Tags :U.S. Food and Drug Administration
The FDA issues the first warning letters following its marketing denial orders. Read More
The rules reflect clarifying changes but no significant substantive changes.Read More
Turning Point accuses the FDA of ‘moving the goalposts’ for a marketing application. Read More
The organizations cite concerns about youth appeal and public health impact.Read More
As of Sept. 23, the agency has issued 323 MDOs accounting for more than 1,167,000 ENDS.Read More
The rejections include products from prominent players such as Turning Point and Avail. Read More
Companies find themselves torn between their obligations to the law and to the safety of users. Read More
The presentations focus on the Office of Small Business Assistance and warning letters. Read More
The company says it will continue its dialogue with the agency.Read More
