• 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...
  • Bill Would Address Medical Device Safety By Giving FDA Additional Authority

    A new bill introduced in the Senate would address medical device safety by giving the US Food and Drug Administration (FDA) additional authority to conduct postmarketing surveillance. "Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market," said Senator Jeff Merkley, the bill's chief sponso...
  • FDA Asked To Explain Email Monitoring Policies

    Senator Chuck Grassley (R-IA) and Representative Darrell Issa (R-CA) sent a letter to the US Food and Drug Administration (FDA) about their monitoring of nine employees who worked for the agency. The letter demands a comprehensive explanation of all FDA monitoring policies after the agency kept tabs on emails sent by the nine workers to federal watchdog agencies. In the letter, sent to Office of Management and Budget (OMB) Acting Budget Director Jeffery Zients, Gras...