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A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States.

• Authors : Hoshino, Yuko; Narukawa, Mamoru

Subjects: DRUG approval; PHARMACOLOGY; DRUG lawsUNITED States; JAPAN

• Source: Therapeutic Innovation & Regulatory Science; Sep2022, Vol. 56 Issue 5, p839-847, 9p

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Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation.

• Authors : Guinn, Daphne; Madabushi, Rajanikanth; Wang, Yow-Ming

Subjects: PHARMACOKINETICS; DRUG interactions; DRUGSUNITED States. Food & Drug Administration

• Source: Therapeutic Innovation & Regulatory Science; 2020, Vol. 54 Issue 6, p1363-1371, 9p

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Outdated Prescription Drug Labeling.

• Authors : Shea, Michael B.; Stewart, Mark; Van Dyke, Hugo

Subjects: ANTINEOPLASTIC agents; DRUG labeling; T-test (Statistics)UNITED States. Food & Drug Administration

• Source: Therapeutic Innovation & Regulatory Science; Nov2018, Vol. 52 Issue 6, p771-777, 7p

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Characterization of Pharmacogenetic Information in Food and Drug Administration Drug Labeling and the Table of Pharmacogenetic Associations.

• Authors : Cheng, Christine M.; So, Thomas W.; Bubp, Jeff L.

• Source: Annals of Pharmacotherapy; Oct2021, Vol. 55 Issue 10, p1185-1194, 10p

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Evaluation of elexacaftor–tezacaftor–ivacaftor treatment in individuals with cystic fibrosis and CFTRN1303K in the USA: a prospective, multicentre, open-label, single-arm trial.

• Authors : Solomon, George M; Linnemann, Rachel W; Rich, Rachel

Subjects: CYSTIC fibrosis; CYSTIC fibrosis transmembrane conductance regulator; DRUG labeling

• Source: Lancet Respiratory Medicine; Dec2024, Vol. 12 Issue 12, p947-957, 11p

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Unleashing the Power of Reliance for Post-Approval Changes: A Journey with 48 National Regulatory Authorities.

• Authors : Mangia, Francesca; Lin, Yameng; Armando, John

Subjects: GOVERNMENT agencies; DRUG approval; PHARMACEUTICAL industryWORLD Health Organization; EUROPEAN Union

• Source: Therapeutic Innovation & Regulatory Science; Nov2024, Vol. 58 Issue 6, p997-1005, 9p

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A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States

• Authors : Hoshino, Yuko; Narukawa, Mamoru

• Source: Therapeutic Innovation and Regulatory Science; September 2022, Vol. 56 Issue: 5 p839-847, 9p

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Making Changes: Generic Drug Labeling and the Case Against Federal Preemption.

• Authors : Stout, Lesley A.

Subjects: GENERIC drugs; DRUG approval; EXCLUSIVE & concurrent legislative powersUNITED States

• Source: Kentucky Law Journal; 2009/2010, Vol. 98 Issue 3, p623-651, 29p

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Overdosage Section in US and EU Labeling.

• Authors : Condon, Sarah; Cantu, Thomas G.; Constantinou, Antony

Subjects: DRUG overdose; RISK assessment; MEDICAL protocolsUNITED StatesUNITED States. Food & Drug Administration; EUROPEAN Union

• Source: Therapeutic Innovation & Regulatory Science; Sep2024, Vol. 58 Issue 5, p946-952, 7p

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An analysis of in-hospital enoxaparin prescription and bleeding in the predominately middle-, and oldest-old population: insights from a secondary care hospital.

• Authors : Angsunid Porncatatak; Sathaporn Khananthai; Mathumalar Loganathan

Subjects: HEMORRHAGE risk factors; INAPPROPRIATE prescribing (Medicine); RISK assessmentTHAILAND

• Source: Pharmacy Practice (1886-3655); Jul-Sep2024, Vol. 22 Issue 3, p1-13, 13p

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