Despite some rumbling about his ties to the pharmaceutical and tech industries, Robert Califf breezed through a two-hour nomination hearing on Tuesday for a second stint as commissioner of the US Food and Drug Administration (FDA).   Califf’s nomination by President Joe Biden last month came after a protracted period of speculation as to who would be chosen to lead FDA at an unprecedented time in the agency’s history. During the hearing, Califf laid out three overarchi...

Senate HELP Committee Chairman Lamar Alexander (R-TN) on Wednesday delayed an expected vote on Scott Gottlieb's nomination to head the US Food and Drug Administration (FDA). Alexander said the vote was being delayed to give senators more time to "consider whatever information they want to consider and fit the schedules of senators who are all over the capital." According to Committee Ranking Member Patty Murray (D-WA), senators would need the extra time to review Gottli...

RAPS has opened the nomination process for four open positions on its board of directors for the 2017–19 term. Regulatory leaders are needed to serve as president-elect, treasurer and directors (two open positions). Nominations and supporting materials, including resume or curriculum vitae (CV) and two letters of support, must be submitted to RAPS by 1 June 2016. Nominees must be active RAPS members in good standing. “This is a great opportunity to lead the pre...

The US Senate on Tuesday voted 89 to 4 to confirm Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA). Califf's path to confirmation was made clear after a procedural vote Monday evening, when senators voted 80 to 6 to move the nomination to a vote. In September, President Barack Obama nominated Califf to replace Margaret Hamburg, who resigned in March after leading FDA for six years and was replaced in th...

RAPS is seeking regulatory leaders to serve on its board of directors for the 2016–2018 term. Nominations and all supporting materials, including resume or curriculum vitae (CV) and two letters of support, are due to RAPS by 1 May 2015. Nominees must be full members in good standing. RAPS is looking to fill the positions of president elect and three directors. The board is the organization’s strategic governing and policy body. To submit a nomination, first revie...

The US Food and Drug Administration (FDA) is calling for the nomination of consumer representatives for its public advisory committees. FDA uses the advisory panels to review high-risk drug products or pressing issues that warrant a transparent discussion of the issues and allow for public comment. Though regulators are free to disregard the final opinions of the committee-and occasionally do, most often when the panel is deeply divided-the committees' opinions often for...

US regulators are calling for the nomination of new members of several prominent advisory committees it uses to formulate non-binding but influential recommendations. The committees often serve as a pre-review stage for new or controversial products, and the views of its committee members regularly act as a barometer for safety, efficacy and quality concerns. In a Federal Register notice released 4 October, the US Food and Drug Administration (FDA) said it is aw...