FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBER’s next director.
FDA cites Pfizer over social media promotions for its cancer drug Adcetris, stating that certain Facebook advertisements are “false or misleading.”
FDA is reportedly considering ophthalmologist and biotech executive Houman Hemmati as CBER’s next director.
FDA cites Pfizer over social media promotions for its cancer drug Adcetris, stating that certain Facebook advertisements are “false or misleading.”
A panel of industry leaders, policy experts, and FDA say broader adoption of external control arms in oncology drug development will depend on improved data quality, closer collaboration with regulators and clearer expectations around evidentiary standards.
FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requirements to publicly report study results on ClinicalTrials.gov, amid concerns about widespread underreporting and potential bias in the scientific record. The agency said the outreach, conducted 3/
