US Food & Drug Administration Commissioner Robert Califf’s was sworn in earlier this year with an unsurpassed resume for the job: he had done it before.
US FDA Commissioner Califf’s Baptism By Fire – Or, At Least, Formula
Robert Califf’s second tenure as FDA commissioner already feels different from the first, thanks to a national shortage of infant formula – and an abundance of questions about what FDA could have done to prevent it.

More from Agency Leadership
More from Pink Sheet
Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.
Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.