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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
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
Drugmakers and trade groups overwhelmingly want lower user fees and a clearer review process for GDUFA as the FDA looks to renew the user fees before the Sept. 30, 2017 cut-off date. Read More
The House Appropriations Committee passed a fiscal 2017 agricultural appropriations bill in April that proposes a slight funding increase for the FDA, but still remains well below the agency’s funding request. Read More