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Research article

First published 1991-10

International Approval Process for Clinical Documents

Betty R. Kuhnert

Therapeutic Innovation & Regulatory Science

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Research article

First published 1995-1

Experience with an International Approval Process for Clinical Documents

Betty R. Kuhnert

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2024-9

Investigating Variations in Medicine Approvals for Attention-Deficit/Hyperactivity Disorder: A Cross-Country Document Analysis Comparing Drug Labeling

Laila Tanana, Asam Latif, Prasad S Nishtala [...]

Journal of Attention Disorders

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Letter

First published 2007-12

Accessing FDA Approval Packages and Briefing Documents

Joseph Ohmer, Jeffrey W Miller, Larry D Sasich

Annals of Pharmacotherapy

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Research article

First published 2025-7

Content and Readability of Informed Consent Documents Approved by Research Ethics Committees of Health Institutions in South-East Nigeria

Onyinye Chime, Emmanuel Ezeome

Journal of Empirical Research on Human Research Ethics

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Research article

First published 2025-10

Mapping land use regulation and urban characterisation in territorial spatial planning of Chinese cities

Haoyu Hu, Lie Wang, Haiyan Lu

Environment and Planning B: Urban Analytics and City Science

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Research article

First published 2012-04

FDA Releases Program for Approval of Biosimilars DOCUMENT: Draft Guidance for Industry from FDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product DOCUMENT: Draft Guidance for Industry from FDA: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Biotechnology Law Report

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Other

First published 2010-04

Risk Management Plan Issued for Erythropoietin;U.S.–European Agreement to Reduce Burden of Orphan Drug Documentation;New Product Approvals from FDA;FDA,NIH Form Partnership to Improve Regulation

Biotechnology Law Report

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Research article

First published 2011-9

How Often are Ethics Approval and Informed Consent Reported in Publications on Health Research in Cameroon? A Five-Year Review

Nchangwi Syntia Munung, Chi Primus Che, Odile Ouwe-Missi-Oukem-Boyer [...]

Journal of Empirical Research on Human Research Ethics

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Research article

First published 2001-4

Communicating Style Rules to Editors of International Standards: An Analysis of ISO TC 184/SC4 Style Documents

Thomas L. Warren

Journal of Technical Writing and Communication

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