FDA Directives From House Range From Antibiotics To Zohydro
This article was originally published in The Pink Sheet Daily
Draft appropriations committee report instructs FDA to undertake tasks both profound (offer a better accounting of how user fees are spent) and routine (meet with patient communities for specific diseases).
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Durata has honor of having first drug approved under Qualified Infectious Disease Product designation and gains the benefits of an added five years of market exclusivity.
Agency planned for up to 100 participants in program allowing expedited entry of some imports, but only approved 13.
GAO says ongoing drug shortages are increasing, but FDA says they are flattening; contrasting definitions of “shortage” produce the disparate results.