Tag: oncology

oncology

Regulatory/FDA

OPDP Experimental Study to Examine Targeted Mechanism of Action Claims

OPDP Experimental Study to Examine Targeted Mechanism of Action Claims

Nov. 8, 2021 – Whether consumers and healthcare professionals (HCPs) are influenced by “targeted mechanism of action (MoA)” presentations in promotional materials for drugs is the subject of a proposed study by FDA’s Office of Prescription Drug Promotion (OPDP) research division. Public comments on the information collection activities associated with this research proposal are due […]

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Regulatory/FDA

FDA Establishes Office of Oncologic Diseases to Streamline Drug Review Process

FDA Establishes Office of Oncologic Diseases to Streamline Drug Review Process

Nov. 8, 2019 – The FDA announced this week that it has reorganized its office that reviews applications for new and existing cancer therapies; its Office of Hematology Oncology Products has been renamed the Office of Oncologic Diseases (OOD) and has six divisions to accommodate a more streamlined drug review process, according to a Nov. […]

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Europe Beating U.S. Hands Down in Oncology

Thanks to Tom Sullivan’s Policy and Medicine blog for this report on Medscape’s video about why U.S. restrictions on industry support of CME are hindering progress in vital medical fields. An interesting video and script  from MedScape recently discussed a troubling trend in clinical research regarding gastrointestinal (GI) cancers. According to John L. Marshall, Associate Professor […]

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