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The FDA has hit Oeyama-Moto Cancer Research Foundation’s IRB for failing to define its operational protocol, leading to inadequate communication with clinical investigators and meager documentation. Read More
As the FDA ramps up its preparations for renewing PDUFA, industry and related groups are pushing for a greater focus on patient perspectives to inform clinical research. Read More
Sponsors with pending NDAs and ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
The European Medicines Agency is providing guidance on how drugmakers can best incorporate patient-reported outcomes in developing oncology studies. Read More
Clovis Oncology is stopping development of its lung cancer candidate rociletinib after the FDA warned the company of a potential complete response letter. Read More
Companies developing direct-acting antiviral hepatitis C drugs should factor in interferon treatment when designing clinical trials, the FDA said. Read More
Two FDA advisory committees recommended the FDA approve KemPharm’s opioid pill Apadaz, even though they rejected an abuse-deterrent label for the candidate. Read More
To bridge the gulf between the promise of biosimilars on drug pricing and the reality, payors should incentivize biosimilar utilization, a new report states. Read More