One Step Forward, Two Steps Back: Regulatory Reform May Be Tougher On CMS Than On FDA

President-Elect Trump is putting new meaning in the catch phrase “doubling down”: promising an executive order to require agencies to withdraw two old regulations any time they issue a new one. That may be a big challenge for CMS – and also complicate some aspects of FDA’s activities.

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FDA’s push to reinvent the OTC monograph process is likely to become much more urgent if the Trump Administration follows through on plans for regulatory reform.

In a YouTube video released Nov. 21, President-Elect Donald Trump repeated a campaign promise to issue an executive...

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PS-AgencyLeadership (Premium-1): Study Reveals How Immune System of Astronauts Breaks Down

Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.

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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.

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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.