FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.
Can the proprietary names of prescription drugs sway perceptions about their efficacy and benefits and risks?
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.
Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.
A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.
Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.
While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.
Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?
