CooperSurgical Lands US FDA Warning Letter Over ParaGuard TV Spot
The agency's "Bad Ad" program issued a warning letter that claims the promotion for CooperSurgical's copper-containing intrauterine contraceptive lacked any safety information.
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‘Untitled’ letter is FDA's third in the past eighteen months to target promotions for women’s health products. In the case of advertisement for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug, the agency took issue with distracting visuals and reliance on superimposed text.
CDC’s ACIP likely to discuss criteria needed to lift pause and whether to recommend that the vaccine not be used in specific groups. Former CBER official says FDA and CDC will look at reports for other adenovirus vector vaccines, including J&J’s Ebola vaccine, and the biological plausibility that cases of rare blood clots are directly associated with the vaccine.
NCI networks had vast under accrual in the past year, but Sharpless says industry has been affected to a greater degree. He says the institute also has been better at accruing minority patients.