Live From BIO: FDA center directors discuss upcoming challenges

CHICAGO - FDA Commissioner Margaret Hamburg was joined by acting CBER Director Karen Midthun and CDER Deputy Director Douglas Throckmorton in addressing some of the challenges currently facing the agency. During her presentation, Hamburg emphasized the need for a strong FDA that makes both the public and industry confident. She added that it is imperative for the agency to attract and retain the best scientists in order to bring fresh ideas. The agency also needs to continue to recognize that...

Live From BIO 2010: Hamburg discusses advancing regulatory science

CHICAGO - FDA Commissioner Margaret Hamburg addressed attendees at the BIO 2010 conference, where she emphasized the need to strengthen regulatory science to evaluate the safety and efficacy of products more quickly to get them to the people. Without strengthening regulatory science, many promising technologies may be abandoned because there wasn't the know-how to see their potential. She added that she wants the FDA to serve as a gateway, not a barrier, for allowing products to get to the...

FDA wants more details on panel members’ potential conflicts

The FDA plans to pull one more veil off any potential conflicts of interest among the experts recruited for the regulatory group's influential review panels. The agency posted a proposal to require panel members to disclose the names of any companies or institutions that could create a conflict for them. For the past two years, panel members have only had to state whether they worked for a sponsor or competitor of a drug or device being reviewed. The agency also plans to provide an idea of the...