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Articles (56)

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1-10 of 56 results for biologics license application

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

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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: 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

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

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Research article

First published 2011-1

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

Danial E. Baker

Hospital Pharmacy

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

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Research article

First published 2011-7

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

Danial E. Baker

Hospital Pharmacy

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

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Research article

First published 2011-3

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

Danial E. Baker

Hospital Pharmacy

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

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Research article

First published 2010-6

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

Danial E. Baker

Hospital Pharmacy

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

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Research article

First published 2010-2

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

Danial E. Baker

Hospital Pharmacy

Select article: Statistical Issues in Biologics Submissions to the FDA

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Research article

First published 1996-10

Statistical Issues in Biologics Submissions to the FDA

Cornelius J. Lynch, Peter A. Lachenbruch

Therapeutic Innovation & Regulatory Science

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