Three months after his nomination by President Joe Biden, and despite weeks of uncertainty over whether he could muster enough Republican votes to overcome Democratic defectors in a narrowly split Senate, Robert Califf was confirmed as commissioner of the US Food and Drug Administration (FDA) for the second time on Tuesday in a 50-46 vote.   The vote came after the confirmation cleared a procedural hurdle on Monday, in which five Republicans joined most Democrats in ...

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...

Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him. Califf did his best to quell any concerns over industry influencing his decisions as head of the agency and the majority of senators at the hearing seemed confident that his experience makes him the right...

On 2 July 2013, new rules are set to go into effect in the European Union that radically change the process by which active pharmaceutical ingredients (APIs) manufactured outside the EU enter into the region. And while many countries are scrambling to get basic systems into place that will allow the manufacturers they regulate to meet the rules, Japan has now joined a small but elite group of nations that will be able to bypass many of the rules' most onerous provisions. ...

What's next for the White House's Office of Information and Regulatory Affairs (OIRA)? The agency, a sub-agency of the Office of Management and Budget (OMB), is sometimes referred to as the regulator of regulators; the agency charged with reviewing regulations promulgated by other agencies to ensure they meet federal guidelines and are generally cost-effective and minimally burdensome. That mission has made it the bane of more than a few regulatory agencies, including ...