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WASHINGTON — President Trump on Tuesday called on the Food and Drug Administration to speed the approval of drugs to treat life-threatening diseases, deriding the agency’s current process as “slow and burdensome.”

In an address to a joint session of Congress, Trump said that the FDA approval process “keeps too many advances … from reaching those in need.”

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  • Approving Cempra’s solithromycin (an antibiotic) without requiring the extra financially burdensome safety studies the FDA asked for in December (the company just laid off about 67% of their personnel due to this unexpected demand) could be one of the very first “quick wins” that the Trump administration can rapidly accomplish.

    For more info, see: “Cempra’s Solithromycin And The Great FDA Echo Chamber”, on Seeking Alpha. (An account is needed past the first page.)

    • So, you would rather the public complete the safety studies for Cempra by consuming an inadequately characterised drug? I would add that potential hepatotoxicity is not a trifling thing.

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