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Articles (45)

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1-10 of 45 results for premarket review

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Select article: Recalls and Premarket Review Systems for High-Risk Medical Devices in Japan

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Research article

First published 2019-11

Recalls and Premarket Review Systems for High-Risk Medical Devices in Japan

Motoko Nakayama, Shiro Tanaka, Shota Hamada [...]

Therapeutic Innovation & Regulatory Science

Select article: The Regulatory Approach to Medicines in New Zealand

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Research article

First published 1996-10

The Regulatory Approach to Medicines in New Zealand

Abdul F. Mutlib

Therapeutic Innovation & Regulatory Science

Select article: Immunogenetically Controlled Autoimmune Reactions Induced by Mercury,Gold and D-Penicillamine in Laboratory Animals: a Review from the Vantage Point of Premarketing Safety Studies

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Review article

First published 1987-7

Immunogenetically Controlled Autoimmune Reactions Induced by Mercury,Gold and D-Penicillamine in Laboratory Animals: a Review from the Vantage Point of Premarketing Safety Studies

Tibor Balazs

Toxicology and Industrial Health

Select article: The FDA's Medical Dictionary for Drug Regulatory Affairs Alpha Test

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Research article

First published 1995-10

The FDA's Medical Dictionary for Drug Regulatory Affairs Alpha Test

Kathryn Huntley, Mary Jo Veverka, Minna Golden

Therapeutic Innovation & Regulatory Science

Select article: The Regulation of Biological Products and the CBER-CDER Intercenter Agreements

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Research article

First published 1993-7

The Regulation of Biological Products and the CBER-CDER Intercenter Agreements

Michael E. Margolies

Therapeutic Innovation & Regulatory Science

Select article: Regulatory Aspects of Invasive Glucose Measurements

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Research article

First published 2002-12

Regulatory Aspects of Invasive Glucose Measurements

Steve Gutman, Patricia Bernhardt, Arleen Pinkos [...]

Diabetes Technology & Therapeutics

Select article: Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making,2016–2024

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Research article

First published 2026

Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making,2016–2024

Louis Y Li, Reshma Ramachandran, Joseph S Ross [...]

Clinical Trials

Select article: Statistical Evaluation of Drug Safety Data

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Research article

First published 2014-1

Statistical Evaluation of Drug Safety Data

H. Amy Xia, Qi Jiang

Therapeutic Innovation & Regulatory Science

Select article: Controlling CRISPR Through Law: Legal Regimes as Precautionary Principles

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Research article

First published 2019-10

Controlling CRISPR Through Law: Legal Regimes as Precautionary Principles

Jacob S. Sherkow

The CRISPR Journal

Select article: High-Technology Theories and Public Policy

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Research article

First published 1989-6

High-Technology Theories and Public Policy

C Thompson

Environment and Planning C: Politics and Space

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