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Articles (128)

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1-10 of 128 results for biological licensing

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Select article: Regulatory Perspective for Biologics License Application of Recombinant Adeno-Associated Virus Products in China

Open access

Review article

First published 2026-1

Regulatory Perspective for Biologics License Application of Recombinant Adeno-Associated Virus Products in China

Jing Cui, Wenbo Wang, Dan Liu [...]

Human Gene Therapy

Select article: Submitting Biologics Applications to the Center for Biologics Evaluation and Research Electronically

Retricted access

Other

First published 1999-1

Submitting Biologics Applications to the Center for Biologics Evaluation and Research Electronically

Mary A. Buesing, Edward McSweegan

Therapeutic Innovation & Regulatory Science

Select article: Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

Retricted access

Research article

First published 2009-02

Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

Biotechnology Law Report

Select article: ‘Creepy,’ ‘freaky,’ and ‘strange’: How the ‘uncanny’ can illuminate the experience of single mothers by choice and lesbian couples who buy ‘dad’

Retricted access

Research article

First published 2013-7

‘Creepy,’ ‘freaky,’ and ‘strange’: How the ‘uncanny’ can illuminate the experience of single mothers by choice and lesbian couples who buy ‘dad’

Linda L. Layne

Journal of Consumer Culture

Select article: CRISPR Therapeutics,Vertex Complete Rolling Biologics License Applications for Exa-Cel in Sickle Cell Disease,Beta Thalassemia

Retricted access

Brief report

First published 2023-05

CRISPR Therapeutics,Vertex Complete Rolling Biologics License Applications for Exa-Cel in Sickle Cell Disease,Beta Thalassemia

Alex Philippidis

Human Gene Therapy

Select article: The Complexity of Compliance in Sample Management: A Review of Key Issues Impacting Small-Molecule and Biological Sample Management in Early Drug Discovery

Free access

Review article

First published 2019-6

The Complexity of Compliance in Sample Management: A Review of Key Issues Impacting Small-Molecule and Biological Sample Management in Early Drug Discovery

Susan Crimmin, Sara Grab, Nicole Greenwood [...]

Journal of Laboratory Automation

Select article: Impact of immunogenicity on clinical efficacy and toxicity profile of biologic agents used for treatment of inflammatory arthritis in children compared to adults

Open access

Review article

First published 2021

Impact of immunogenicity on clinical efficacy and toxicity profile of biologic agents used for treatment of inflammatory arthritis in children compared to adults

Chinar R. Parikh, Jaya K. Ponnampalam, George Seligmann [...]

Therapeutic Advances in Musculoskeletal Disease

Select article: Statistical Issues in Biologics Submissions to the FDA

Retricted access

Research article

First published 1996-10

Statistical Issues in Biologics Submissions to the FDA

Cornelius J. Lynch, Peter A. Lachenbruch

Therapeutic Innovation & Regulatory Science

Select article: New Drugs Approved by the FDA/New Dosage Forms and Indications Approved by the FDA/New Drug/Biologics License Applications Filed by Manufacturer/Significant Labeling Changes or “Dear Health Professional” Letters Related to Safety

Retricted access

Research article

First published 2011-12

New Drugs Approved by the FDA/New Dosage Forms and Indications Approved by the FDA/New Drug/Biologics License Applications Filed by Manufacturer/Significant Labeling Changes or “Dear Health Professional” Letters Related to Safety

E. Baker Danial

Hospital Pharmacy

Select article: Ocular adverse effects of therapeutic biologics

Open access

Review article

First published 2022

Ocular adverse effects of therapeutic biologics

Helio V. Neves da Silva, John Placide, Anne Duong [...]

Therapeutic Advances in Ophthalmology

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