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.

Califf and baby formula
The baby formula shortage has put the challenges of being FDA commissioner into stark relief. • Source: Nielsen Hobbs; the Pink Sheet | Alamy and Shutterstock images

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.

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Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

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.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 

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.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 

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.