FDA Is Built on Predictability and Expertise, Not Norm-Breaking

This week’s FDA Matters column, entitled “FDA is Built on Predictability and Expertise, Not Norm-Breaking,” can be found here.

My position has been “whatever you think of the specific policies and actions that Commissioner Makary is pursuing, and 2/ whatever you think of his leadership and management styles....we must speak our truth AND YET also make clear that we support his leadership of FDA.”

Unfortunately, the situation at FDA has deteriorated over the last few weeks. The downside risk has increased greatly. To understand why, please read my column here.

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FDA Matters analyzes FDA policy and regulatory issues and advocates for a more effective, efficient, and fair FDA.

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