Search results: Sage Journals

Open accessReview articleFirst published January, 2026

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

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

Human Gene Therapy

Restricted accessOtherFirst published January, 1999

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

Mary A. Buesing, Edward McSweegan

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published February, 2009

Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

Biotechnology Law Report

Restricted accessResearch articleFirst published July, 2013

‘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

Restricted accessBrief reportFirst published May, 2023

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

Alex Philippidis

Human Gene Therapy

Free accessReview articleFirst published June, 2019

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

Open accessReview articleFirst 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

Restricted accessResearch articleFirst published October, 1996

Statistical Issues in Biologics Submissions to the FDA

Cornelius J. Lynch, Peter A. Lachenbruch

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published December, 2011

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

Open accessReview articleFirst published 2022

Ocular adverse effects of therapeutic biologics

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

Therapeutic Advances in Ophthalmology

Open accessReview articleFirst published January, 2026

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

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

Human Gene Therapy

Restricted accessOtherFirst published January, 1999

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

Mary A. Buesing, Edward McSweegan

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published February, 2009

Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

Biotechnology Law Report

Restricted accessResearch articleFirst published July, 2013

‘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

Restricted accessBrief reportFirst published May, 2023

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

Alex Philippidis

Human Gene Therapy

Free accessReview articleFirst published June, 2019

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

Open accessReview articleFirst 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

Restricted accessResearch articleFirst published October, 1996

Statistical Issues in Biologics Submissions to the FDA

Cornelius J. Lynch, Peter A. Lachenbruch

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published December, 2011

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

Open accessReview articleFirst published 2022

Ocular adverse effects of therapeutic biologics

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

Therapeutic Advances in Ophthalmology