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Oeyama-Moto is in the hot seat yet again after the FDA accused the company of violating a clinical hold the agency had placed on a clinical trial. Read More
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