FDA will re-examine its direct-to-consumer broadcast policy in two years to assess the effect of its proposal to relax the brief summary requirement in TV and radio ads, the agency said in an Aug. 8 Federal Register notice.
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The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.
