By Michael McCaughan
Whoever said actions speak louder than words hasn’t been paying attention to the regulatory response to drug safety issues involving...
Relabeling EPO: Closing the Books on a Safety Issue, Opening a New Chapter at FDA
The relabeling of Aransep and Procrit to address safety issues is taking longer than expected. There's nothing new about that. What is new is how FDA weighed in on the Congressional debate over coverage for the anemia therapies-and how the last step of the regulatory process is likely to play out.
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