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The European Medicines Agency is providing guidance on how drugmakers can best incorporate patient-reported outcomes in developing oncology studies. Read More
The Secretary’s Advisory Committee on Human Research Protections is recommending revisions to the Common Rule that would provide further guidance on single IRB reviews. Read More
European regulators are proposing a series of indirect methods for driving down prescription drug costs without stepping outside the science-focused parameters of their roles. 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
The European Medicines Agency is providing guidance on how drugmakers can best incorporate patient-reported outcomes in developing oncology studies. Read More