Topic: FDA warning letter
The FDA’s promotional enforcement squad wasn’t very active in 2016—until December, that is. This month, they've cited six drugmakers, more than half the enforcement actions all year.
Last week's FDA admonishment of Celgene and Sanofi for DTC TV ads has industry insiders checking the tea leaves for what the letters might signal. The upshot? Possibly an end to overly happy and energetic lifestyle pharma ads.
Two pharmas just received less-than-joyful mail from the FDA's ad enforcers.
A North Carolina company that makes transdermal patches has gotten an FDA warning letter for releasing subpotent transdermal pain patches.
A Spanish API maker was criticized in an FDA warning letter for poor cleaning procedures, as well as for issues with equipment that was repaired with materials the agency said might actually affect the quality of its APIs.
The FDA has issued a warning letter to a Chinese heparin maker for some of the same kinds of issues raised by the EU earlier this year.
In this week's FiercePharmaAsia wrap-up, China has become first to test CRISPR in human, GSK is being sued by private investigators, and more.
For the second time in recent weeks, the FDA has slapped a Japanese API maker with a warning letter, this time for data integrity problems at Sekisui Medical.
The FDA has savaged a Chinese API maker in a warning letter for a long list of violations, including hiding questionable products, lying to inspectors about products made at the Beijing plant and systemic data manipulation.
A Czech drugmaker that ships both APIs and finished products to the U.S. has come under fire from the FDA in a warning letter for data integrity issues that the agency says leave questions about the quality of the company’s drugs.