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The draft guidance says source criteria will come from FDA staff, literature, and data from existing devices, but it makes no mention of input from healthcare professionals and other stakeholders. Read More
“I thought the efficacy data was very strong,” said committee member Dean Follmann, assistant director for biostatistics at the National Institute of Allergy and Infectious Diseases. “When we do a pooled analysis to compare it to primaquine we see they’re very similar.” Read More
The allegations “suggest that PBMs and drug distributors are acting to maintain high list prices in order to maintain high profit margins, potentially raising antitrust concerns,” the June 29 letters state. Read More