FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W1598622645> ?p ?o ?g. }

• W1598622645 abstract "ABSTRACT Comparing the safety of prescription drugs over time is difficult due to the paucity of reliablequantitative measures of drug safety. Both the acad emic literature and popular press have focusedon drug withdrawals as a proxy for breakdowns in th e drug safety system. This metric, however, isproblematic because withdrawals are rare events , and they may be influenced by factors beyond adrug's safety profile. In the current paper, we propose a new measure: the incidence and timing ofBlack Box Warnings (BBWs). BBWs are warnings placed on prescription drug labels when a drugis determined to carry a significant risk of a serious or life-threatening adverse event. Using a uniquedata set, one that includes all new molecular entities (NMEs) submitted to the FDA between May1981 and February 2006, and subsequently approved and marketed, we analyze the timing andincidence of BBWs. Our analyses also use data on several drug characteristics likely to affect theprobability a new drug will receive a BBW. We draw several conclusions from our analyses. Forexample, drugs receiving priority FDA review are more likely to have BBWs at the time of approvalthan NMEs receiving standard review. We also find that early prescription volume and orphan drugstatus are associated with an increased like lihood of receiving a BBW. We do not, however, find asignificant difference in the rate of BBWs across time cohorts. A comparison of NMEs approvedbefore and after the 1992 Prescription Drug User Fee Act (PDUFA), which authorized the paymentof user fees from drug manufacturers to the FDA in an effort to expedite new drug application(NDAs) review times, did not reveal a statistically significant difference in the rate of BBWs. Criticsof PDUFA maintain that reduced FDA-approval times under PDUFA have compromised drugsafety. We do not find empirical support for this contention. Allan BegoshSuite 15-36Office of the CommissionerFood and Drug Administration5600 Fishers LaneRockville, MD 20857allan.begosh@FDA.govJohn GoldsmithSuite 15-36Office of the CommissionerFood and Drug Administration5600 Fishers LaneRockville, MD 20857jcgoldsm@erols.comEd HassSuite 15-36Office of the CommissionerU.S. Food and Drug Administration5600 Fishers LaneEd.Hass@FDA.HHS.GOVRandall W. LutterSuite 15-36Office of the CommissionerFood and Drug Administration5600 Fishers LaneRockville, MD 20857Rlutter@oc.fda.govClark NardinelliSuite 15-36Office of the CommissionerFood and Drug Administration5600 Fishers LaneRockville, Maryland 20857Clark.Nardinelli@FDA.HHS.GOVJohn A. VernonUniversity of ConnecticutDepartment of Finance2100 Hillside RoadStorrs, CT 06269Office of the Commissioner, US FDAand NBERjvernon@business.uc" @default.
• W1598622645 created "2016-06-24" @default.
• W1598622645 creator A5035458321 @default.
• W1598622645 creator A5040481215 @default.
• W1598622645 creator A5057133861 @default.
• W1598622645 creator A5061647030 @default.
• W1598622645 creator A5065714095 @default.
• W1598622645 creator A5091572202 @default.
• W1598622645 date "2006-12-01" @default.
• W1598622645 modified "2023-10-04" @default.
• W1598622645 title "Black Box Warnings and Drug Safety: Examining the Determinants and Timing of FDA Warning Labels" @default.
• W1598622645 cites W1592298907 @default.
• W1598622645 cites W2031723179 @default.
• W1598622645 cites W2140747207 @default.
• W1598622645 cites W2152657402 @default.
• W1598622645 cites W3122252013 @default.
• W1598622645 cites W3122499423 @default.
• W1598622645 doi "https://doi.org/10.3386/w12803" @default.
• W1598622645 hasPublicationYear "2006" @default.
• W1598622645 type Work @default.
• W1598622645 sameAs 1598622645 @default.
• W1598622645 citedByCount "7" @default.
• W1598622645 countsByYear W15986226452014 @default.
• W1598622645 countsByYear W15986226452015 @default.
• W1598622645 countsByYear W15986226452016 @default.
• W1598622645 countsByYear W15986226452022 @default.
• W1598622645 crossrefType "report" @default.
• W1598622645 hasAuthorship W1598622645A5035458321 @default.
• W1598622645 hasAuthorship W1598622645A5040481215 @default.
• W1598622645 hasAuthorship W1598622645A5057133861 @default.
• W1598622645 hasAuthorship W1598622645A5061647030 @default.
• W1598622645 hasAuthorship W1598622645A5065714095 @default.
• W1598622645 hasAuthorship W1598622645A5091572202 @default.
• W1598622645 hasBestOaLocation W15986226451 @default.
• W1598622645 hasConcept C108827166 @default.
• W1598622645 hasConcept C154945302 @default.
• W1598622645 hasConcept C2780035454 @default.
• W1598622645 hasConcept C2909938333 @default.
• W1598622645 hasConcept C41008148 @default.
• W1598622645 hasConcept C71924100 @default.
• W1598622645 hasConcept C94966114 @default.
• W1598622645 hasConcept C98274493 @default.
• W1598622645 hasConceptScore W1598622645C108827166 @default.
• W1598622645 hasConceptScore W1598622645C154945302 @default.
• W1598622645 hasConceptScore W1598622645C2780035454 @default.
• W1598622645 hasConceptScore W1598622645C2909938333 @default.
• W1598622645 hasConceptScore W1598622645C41008148 @default.
• W1598622645 hasConceptScore W1598622645C71924100 @default.
• W1598622645 hasConceptScore W1598622645C94966114 @default.
• W1598622645 hasConceptScore W1598622645C98274493 @default.
• W1598622645 hasLocation W15986226451 @default.
• W1598622645 hasLocation W15986226452 @default.
• W1598622645 hasLocation W15986226453 @default.
• W1598622645 hasOpenAccess W1598622645 @default.
• W1598622645 hasPrimaryLocation W15986226451 @default.
• W1598622645 hasRelatedWork W1983544050 @default.
• W1598622645 hasRelatedWork W2124466768 @default.
• W1598622645 hasRelatedWork W2125138090 @default.
• W1598622645 hasRelatedWork W2141845144 @default.
• W1598622645 hasRelatedWork W2564299030 @default.
• W1598622645 hasRelatedWork W2748952813 @default.
• W1598622645 hasRelatedWork W2794783788 @default.
• W1598622645 hasRelatedWork W2899084033 @default.
• W1598622645 hasRelatedWork W4213271907 @default.
• W1598622645 hasRelatedWork W2169545258 @default.
• W1598622645 isParatext "false" @default.
• W1598622645 isRetracted "false" @default.
• W1598622645 magId "1598622645" @default.
• W1598622645 workType "report" @default.