Prescription Drug User Fee Act
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.
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Prescription Drug User Fee Act
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.
has abstract
The Prescription Drug User Fee ...... within the NDA review process.
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Wikipage page ID
10,531,326
page length (characters) of wiki page
Wikipage revision ID
1,012,715,709
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acts amended
cite public law
colloquialacronym
PDUFA, DSA
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effective date
1992-10-29
enacted by
introducedby
John Dingell
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introduceddate
1992-10-06
introducedin
House
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leghisturl
longtitle
An Act to amend the Federal Fo ...... t fees and for other purposes.
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nickname
Dietary Supplement Act of 1992
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passedbody
House
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Senate
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passeddate
1992-10-06
1992-10-07
passedvote
passed voice vote
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passed without objection
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public law url
sections amended
§ 379g et seq.
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shorttitle
Prescription Drug User Fee Act
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signeddate
1992-10-29
signedpresident
title amended
wikiPageUsesTemplate
hypernym
type
comment
The Prescription Drug User Fee ...... within the NDA review process.
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label
Prescription Drug User Fee Act
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