• Regulatory NewsRegulatory News

    MDUFA IV: Industry, FDA Iron Out Specifics of $500M Deal

    Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA). In the 27 January meeting, FDA estimated that the additional resources to implement such proposals over the five-year authorization period of MDUFA IV would total $500 million, without inflationary adjustments, and in addition to the base amount of user fees...
  • Regulatory NewsRegulatory News

    Leader Sought for FDA's Influential Office of Device Evaluation

    The US Food and Drug Administration (FDA) is seeking a permanent leader for its medical device-focused Office of Device Evaluation (ODE), the division responsible for reviewing nearly all medical devices marketed in the US. The office was most recently run by Christy Foreman, who stepped down in September 2014 to take a new role within FDA's new Center for Tobacco Products. Bill Maisel, deputy director for science and chief scientist at FDA's Center for Devices and R...
  • Regulatory NewsRegulatory News

    FDA's 'TurboTax' Pilot Program for Medical Devices Expanding

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is expanding a new pilot program that it hopes will make medical device submissions a lot less complicated and a lot more like filing taxes using TurboTax. Background As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "eliminating the need for a ...
  • Regulatory NewsRegulatory News

    One of FDA's Top Device Regulators Stepping Aside

    One of the US Food and Drug Administration's (FDA) top medical device regulators, Christy Foreman, will soon be giving up her position to focus on tobacco regulation at the agency. In an announcement on 19 August 2014, FDA said that Foreman—now director of the Office of Device Evaluation (ODE), the office which oversees approval of all medical devices in the US—will soon assume a new, as-yet undefined role at FDA's Center for Tobacco Products (CTP). Foreman's last day...
  • FDA's OTC Product Review Division Gets Permanent Director

    US drug regulators on Monday announced that Theresa "Terri" Michele, now acting director of the Division of Nonprescription Clinical Evaluation (DNCE) within the Office of Drug Evaluation (ODE) IV, had been appointed to the position of a permanent basis. ODE IV, a division of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), is charged with reviewing imaging products and nonprescription (i.e. over-the-counter) drug products. It...
  • CDRH Official Hits Back at Legislators' Claim that FDA Regulation Stifling Mobile Health Apps

    US regulators fought back Thursday against allegations that the US Food and Drug Administration (FDA) is stifling the innovation of mobile medical applications and other mobile devices by developing frameworks to regulate them, with one agency witness telling legislators that they are trying to walk a fine line between supporting innovation and protecting the public. Background The House Energy and Commerce Committee is in the midst of the three-day meeting regarding FD...
  • Feature ArticlesFeature Articles

    Is FDA Leaving Orphans Out in the Cold?

    • 22 February 2013
    In the last 12 months, the US Food and Drug Administration (FDA) has taken certain actions that, on their face, seem to be potentially limiting the benefits of orphan drug exclusivity (ODE). It is too soon to tell. However, FDA's actions are worth a review, because they demonstrate that the once-sacrosanct ODE is not invincible. At a minimum, it is interesting that, nearly 30 years since the passage of the Orphan Drug Act , the agency's views continue to emerge. Resc...
  • FDA Releases Long-Awaited Draft Guidance on Clinical Trials

    The US Food and Drug Administration (FDA) has released an extensive new guidance document that one of its top drug regulatory officials says is aimed at "greatly increase[ing] the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective." Writing in a blog posting on the FDA Voice blog on 17 December 2012, FDA's Bob Temple, deputy director for clinical science at the Center for Drug Evaluation and Research (CDER), sa...
  • FDA's Bob Temple Moving from ODE-1 to Other Position

    Bob Temple, the US Food and Drug Administration's (FDA) Director of the Office of Drug Evaluation 1 (ODE-1), is fully assuming his role as Deputy Center Director for Clinical Science and giving up his role as the ODE-1 director, reports BioCentury . Temple was first promoted to the position of Deputy Center Director in November 2009, but has remained in ODE-1. Prior to ODE-1, Temple worked in the Office of Medical Policy, which oversaw the then-named Division of Dru...