Sage Journals: Discover world-class research

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

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

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

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

Retricted access

Research article

First published 2013-9

What's in a name?—The identification of biologic products

Ralph G Neas, David R Gaugh

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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

Retricted access

Research article

First published 2009-6

University Contributions to the HPV Vaccine and Implications for Access to Vaccines in Developing Countries: Addressing Materials and Know-How in University Technology Transfer Policy

Sara E. Crager, Ethan Guillen, Matt Price

American Journal of Law & Medicine

Retricted access

Research article

First published 2008-04

Supplemental Applications Proposing Labeling Changes for Approved Drugs,Biologics,and Medical Devices [excerpts]

Biotechnology Law Report

Retricted access

Research article

First published 2018-4

The Prescription Drug User Fee Act: Cause for Concern?

Michael Gabay

Hospital Pharmacy

Free access

Review article

First published 2016-5

Clinical experience with infliximab biosimilar Remsima (CT-P13) in inflammatory bowel disease patients

Jørgen Jahnsen

Therapeutic Advances in Gastroenterology

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