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Pink Sheet editors discuss the highlights and challenges of FDA Commissioner Martin Makary’s first year in office and consider possibilities for year two.

The European Medicines Agency has backed five new medicines for EU approval, with orphan drugs for lung cancer and a rare immunodeficiency disorder in the mix.

The UK drug regulator will review preliminary data from studies that use non-animal models before it assesses a drug marketing authorization application to help developers adopt alternative testing methods.

Martin Makary arrived as FDA commissioner promising “common sense” reforms and faster cures, but layoffs, leadership churn, and sudden policy shifts quickly strained the agency's processes and credibility.

Pharmaceutical companies are placing pressure on Europe’s delicate drug distribution system by supplying direct to pharmacies.

The FDA leader also discussed priorities for his second year, including reforming the IND process and moving more drugs over the counter, in written responses to Pink Sheet questions.