FDA guidance document encourages industry to collect financial records from their clinical trial investigators "in as efficient and least burdensome manner as possible," suggesting the use of questionnaires as opposed to "elaborate internal computerized tracking systems." Disclosure of compensation to clinical investigators conducting studies of products, as well as the investigators' financial interests in study sponsor companies, is required under a Feb. 2 rule. The agency is requesting comments on the guidance, which also addresses industry concerns about the costs of collecting and maintaining the financial records

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.