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Deleted Tweet from Scott Gottlieb, R-D.C.

Deleted Tweet from Scott Gottlieb, M.D.

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SteveFDA (R-D.C.)
@SGottliebFDA

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Products that would be approved under an ANDA or 351(k) biosimilar BLA are not PDUFA-covered products. Nor are OTC monograph drugs, although OTC products approved under NDAs are PDUFA-covered.

Deleted after 49 weeks at 12:09 PM on 18 Dec 19.
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