FDA Funding Bill Clears House Cmte., Defers Action On Compounding

Measure to provide $5.2b to FDA in FY 2018; amendment on office-use compounding withdrawn after House Appropriations Committee agrees to work to get FDA to allow practice.

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The House Appropriations Committee said it would work to get FDA to change its policy on office-use compounding during July 12 markup of the fiscal year 2018 funding bill for the agency.

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US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

Makary’s Reorganization Decision A Turning Point For US FDA?

 

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

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

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How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.

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