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Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act

https://doi.org/10.1086/589934
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What this work says

Outgoing claims: the papers this work cites, builds on, or argues with.

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Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969-2002
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Timing of New Black Box Warnings and Withdrawals for Prescription Medications
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The role of databases in drug postmarketing surveillance
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Approval times and the safety of new pharmaceuticals
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Are novel drugs more risky for patients than less novel drugs?
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The risk we bear: The effects of review speed and industry user fees on new drug safety
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Cost-benefit analysis of the FDA: The case of the prescription drug user fee acts
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The price of innovation: new estimates of drug development costs
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Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates
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The Future of Drug Safety
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An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments
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Pharmaceutical Policy Change and the Safety of New Drugs
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Estimating the Effects of Regulation on Innovation: An International Comparative Analysis of the Pharmaceutical Industry
inferredcites →https://doi.org/10.1177/009286159502900203openalex-snapshot
A Drug Lag Update
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Trends in Drug Development Costs, Times, and Risks
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Clinical Cancer Advances 2005: Major Research Advances in Cancer Treatment, Prevention, and Screening—A Report From the American Society of Clinical Oncology
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Clinical Cancer Advances 2008: Major Research Advances in Cancer Treatment, Prevention, and Screening—A Report From the American Society of Clinical Oncology
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Spending On Postapproval Drug Safety
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The Quantity And Quality Of Worldwide New Drug Introductions, 1982–2003
inferredcites →https://doi.org/10.2139/ssrn.931153openalex-snapshot
FDA New Drug Approval Times, Prescription Drug User Fees, and R&D Spending
inferredcites →https://doi.org/10.2165/00019053-200220003-00002openalex-snapshot
Returns on Research and Development for 1990s New Drug Introductions
inferredcites →https://doi.org/10.2165/00019053-200422002-00003openalex-snapshot
Are the Economics of Pharmaceutical Research and Development Changing?

What points at this work

Incoming claims: where this work appears in other papers’ reference lists and arguments.

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Despite Criticism Of The FDA Review Process, New Cancer Drugs Reach Patients Sooner In The United States Than In Europe
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Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals
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