FDA Matters provides short-form analysis of FDA policy and regulatory issues. We know you are busy, so we publish 1 to 2 columns per week, each a 3-5 minute read.

FDA Matters does not report the news….we provide analysis of what’s behind the news.

FDA Matters advocates for a more effective, efficient, and fair FDA.

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Spotlight: The Partnership for Safe Medicines (PSM)

Spotlight: The Partnership for Safe Medicines (PSM)

Dear FDA Matters readers: FDA Matters’ newest feature puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. Two prior Spotlight columns are here and here. More will follow. If you are aware of a cause or an organization that…

Compounding, Patient Safety, and the Vital Role of FDA Enforcement

Compounding, Patient Safety, and the Vital Role of FDA Enforcement

Over the last two years, few FDA topics have consumed more sustained attention than the mass compounding of commercially available drugs.  GLP-1 (glucagon-like peptide-1 receptor agonists) drugs have been the focus of most of the public discussion. However, our…

Spotlight: Advanced Research Projects Agency for Health (ARPA-H)

Spotlight: Advanced Research Projects Agency for Health (ARPA-H)

Dear FDA Matters readers: This column is the first in a new series that puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. I have a second spotlight column in process and am open to recommendations for future topics. Steven…