Former FDA/OTC Review Director Robert Pinco
Attorney with Washington, D.C. firm Baker & Hostetler reportedly hopes to return to agency as top-level assistant to Commissioner Young. Although he had "no comment" for "The Pink Sheet," Pinco is said to have visited Capitol Hill to garner support for a return to FDA. James Benson has been acting deputy commissioner since June 1988. When Benson took the job, he was believed to be doing it on a temporary basis with the hope that he could return to his previous post as deputy director at the Center for Devices and Radiological Health. That job has not been filled on a permanent basis.
You may also be interested in...
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.