Biologics License Applications (bla) - Toxicology

Relevant Publications

Review of the Food and Drug Administration\'s Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Mid-Cycle Communications.

Issue Release: 2023

Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019-2023) by US FDA, best practices and recommendations.

Issue Release: 2023

Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data.

Issue Release: 2019

Assessment of the approved Risk Evaluation and Mitigation Strategy programs for New Drug Applications and Biologics Licensing Applications.

Issue Release: 2018

A Retrospective Evaluation of the Use of Mass Spectrometry in FDA Biologics License Applications.

Issue Release: 2016

Endotoxin recovery using limulus amebocyte lysate (LAL) assay.

Issue Release: 2016

Participation of women and sex analyses in late-phase clinical trials of new molecular entity drugs and biologics approved by the FDA in 2007-2009.

Issue Release: 2013

Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.

Issue Release: 2008

INGN 201: Ad-p53, Ad5CMV-p53, adenoviral p53, p53 gene therapy--introgen, RPR/INGN 201.

Issue Release: 2007

Antibodies to watch in 2020.

Issue Release: 0000

Are Tolerable Upper Intake Levels the Same for Everyone?

What is the Impact of Lifestyle on Detoxification Organs?

How does secondhand smoke impact non-smokers?

What are Normal Creatinine Levels?

Where Can You Find More Information?

What Are Teratogens?

How Does Toxicology Aid in Risk Assessment?

What is a Firewall in Toxicology?

How Do Genetic Disorders Interact with Toxicology?

How Does Consent Play a Role in Toxicology?

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