Nov. 10, 2011 | Vol. 16 No. 22 | Full Issue in PDF Format
HHS should allow sponsors of clinical trials to appeal IRB denials directly to the department, stipulate that only one IRB need oversee multi-site studies and standardize the content of trial data submissions, companies recommend.
Infeasible study requirements and the regulatory uncertainty they spawn are decreasing chances drugmakers will launch innovative pneumonia antibiotics, a PhRMA representative tells the FDA.
A California ophthalmologist failed to personally conduct or oversee an investigation according to the terms of the investigator statement she signed, earning her an FDA warning letter.
Panel members’ concern at being asked to decide on a supplemental request for approval based on sub-population results instead of primary endpoint data for a drug complicated an FDA advisory committee meeting.
Exelixis plans to initiate its first Phase III trial of cabozantinib for metastatic castration-resistant prostate cancer (CRPC) by the end of the year even though the company hasn’t reached agreement on a special protocol assessment (SPA) with the FDA.
To speed cancer treatment trials and obtain more conclusive results, researchers should enroll participants based on their cancers’ molecular characteristics, a new American Society of Clinical Oncology (ASCO) report recommends.
Sponsors testing cancer vaccines should carefully consider the heterogeneity of the patient population in late-stage trials, an FDA final guidance states.
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