FDA+ roundup: New un­ti­tled let­ter for web ads with­out risk in­fo; PAN­DAs and reg­u­la­to­ry un­cer­tain­ty

The FDA’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion on Tues­day is­sued its third un­ti­tled let­ter of the year to Eton Phar­ma­ceu­ti­cals, ar­gu­ing that some web ads for its hy­dro­cor­ti­sone drug Alkin­di Sprin­kle are mis­lead­ing be­cause they don’t in­clude any in­for­ma­tion on the drug’s risks.

“The spon­sored links are mis­lead­ing be­cause they present claims and/or rep­re­sen­ta­tions about the use and/or ben­e­fits for Alkin­di Sprin­kle but fail to com­mu­ni­cate any risk in­for­ma­tion,” the let­ter dat­ed Aug. 9 said.

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