Supplemental Filings: FDA Can't 'Plug' All Shortage Holes, New Jobs For Billy Dunn, Lisa Parks & Heidi Rebello

From infant formula to drugs, Califf can't get away from shortage work. Plus, the revolving door brings new jobs for some top pharma folks.

supplemental filings

Welcome to another edition of Supplemental Filings, where US-based Pink Sheet reporters offer bonus, quick-hit analysis and insights we think you should know about, but didn't make it into full-length stories.

Addressing the current drug shortage crisis is currently taking up most of US Food and Drug Administration Commissioner Robert Califf’s...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

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Nancy Test Circulable Section Geography

 

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New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

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The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

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New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.