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The FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC) standard the agency has moved towards to gather more study data. Read More
Novartis is facing fresh scrutiny after a Swiss newspaper revealed on Sunday that an unnamed executive at the drugmaker sold nearly $1 million in company stock just weeks before news broke of the data manipulation surrounding Zolgensma, its $2 million spinal muscular atrophy treatment. Read More
Syneos Health offered some suggestions for the FDA’s draft guidance for drugmakers on assessing the risks and benefits of opioids, urging the agency to highlight prior opioid exposure, guidance on tapering use and proper disposal. Read More
The drug received accelerated approval from the FDA in 2017 for treating adults with mantle cell lymphoma who have received at least one prior therapy. Read More