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Latest From Brenda Sandburg
US FDA plans to conduct a study to evaluate consumer comprehension of oncology indications in direct-to-consumer television advertising.
Agency says superimposed text about risks and efficacy is overshadowed by "attention-grabbing before-and-after photographs" of patients treated with the seborrheic keratoses treatment.
US FDA also seeking feedback on whether the agency needs new authorities to better regulate opioid products.
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.
Only 15% of postmarketing commitments for drugs approved in 2009-2012 were for clinical trials and only half of these were published, study finds; authors call for US FDA to provide more trial information.
Advisory committee members are divided on whether agency should restrict access to higher dose opioids, but most want option kept on the table.