• OSE's annual report details Sentinel efforts during COVID pandemic

    The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.   The scope of the office’s charge meant that during the pandemic, staff effort was largely directed toward addressing the global public health emergency of the COVID-19 pandemic, noted Gerald Dal Pan, director of FDA’s Office of Surveillance and Epidemiology (OSE).   However, OSE also continued its efforts in other a...
  • FDA Gets Permanent Director for Reorganized Surveillance 'Super Office'

    The US Food and Drug Administration (FDA) has announced the promotion of Gerald Dal Pan, MD to the position of permanent director of FDA's Office of Surveillance and Epidemiology (OSE), where Dal Pan had been serving as acting director. OSE had recently undergone a reorganization that transformed it from a relatively minor office within the Center for Drug Evaluation and Research (CDER) and into a so-called "super office." Dal Pan has served as the head of OSE since 2005...
  • Post-FDAAA, Regulators Move to Adapt to Changing Risk Models

    With all the attention given to the US Food and Drug Administration's (FDA) approval process, it can sometimes be easy to forget an equal amount of its time is spent on postmarketing issues related, in part, to product safety. Two components of assuring a product's safety involve adverse event reporting (AER) and risk management plans, both of which were the focus of a presentation given at Harvard Medical School in early May 2012. In his presentation, Dr. Gerald Dal Pan...