A Marathon, Not a Sprint: The Long Road to Becoming the Next FDA Commissioner
Around DC, there are a lot of smart people talking about the race to fill the job of FDA Commissioner. To me, it’s more of a slog than a race; certainly, more of a marathon than a sprint. It’s highly unlikely that anyone will be nominated soon, and no one will be confirmed quickly.
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Firing Dr. Makary Solves No Problems….BUT Opens the Door for More Orderly Management and Decision-Making
Drew Armstrong at Endpoints News brilliantly titled his summary of the Makary era: “An Impossible Job, Done Badly.” (here) I could not agree more. Unfortunately, nothing about the “impossible job” of FDA leadership has been made any easier or better by Dr. Makary’s…
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
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: Americans for Medical Progress/Vital Role of Animals in Research
Dear FDA Matters readers: This column is the second in a new series that puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. The first (here) was on the Advanced Research Projects Agency-Health (ARPA-H). Another spotlight…
Speeding Innovative Medicines to Market: Any Delay Matters to Patients
FDA Commissioner Makary has embraced the cause of faster review times for drugs and biologics, an area that holds great promise for bringing innovative drugs to patients more quickly.1 While laudable and likely to succeed, faster drug review times are just one way to…
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…