Investigational New Drug (ind) - Biotechnology

Relevant Publications

Regulatory Considerations for Producing mRNA Vaccines for Clinical Trials.

Issue Release: 2024

Further accelerating biologics development from DNA to IND: the journey from COVID-19 to non-COVID-19 programs.

Issue Release: 2024

Impact of FDA\'s HCT/P ZIKV Recommendations on Cord Blood Unit Eligibility and Utilization in a Large Public Cord Blood Bank.

Issue Release: 2024

Codon-Optimized and de novo-Synthesized E-Selectin/AAV2 Dose-Response Study for Vascular Regeneration Gene Therapy.

Issue Release: 2024

Design and Construction of a Radiochemistry Laboratory and cGMP-Compliant Radiopharmacy Facility.

Issue Release: 2024

Transfusion management and hemoglobin-based oxygen carrier treatment in a patient with anti-Rh17 antibody.

Issue Release: 2024

Regulatory Pathways for Qualification and Acceptance of Digital Health Technology-Derived Clinical Trial Endpoints: Considerations for Sponsors.

Issue Release: 2024

Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea.

Issue Release: 2024

Helicase-primase inhibitors for the treatment of herpes simplex virus infections - patent evaluation of WO2023/225162 from gilead sciences inc.

Issue Release: 2024

Tecovirimat Use under Expanded Access to Treat Mpox in the United States, 2022-2023.

Issue Release: 2024

Human Hepatic Spheroid Coculture Model for the Assessment of Drug-Induced Liver Injury.

Issue Release: 2024

Aggregate IND Safety Reporting for Smaller Companies and Programs.

Issue Release: 2024

Successful Distribution of Tecovirimat During the Peak of the Mpox Outbreak - Los Angeles County, June 2022-January 2023.

Issue Release: 2024

Inclusion of Histopathology in Dose Range-Finding Nonclinical Studies for Inhaled Drug Products.

Issue Release: 2024

A case study of a bispecific antibody manufacturability assessment and optimization during discovery stage and its implications.

Issue Release: 2024

Development and IND-enabling studies of a novel Cas9 genome-edited autologous CD34 cell therapy to induce fetal hemoglobin for sickle cell disease.

Issue Release: 2024

Staying Out of Trouble: FDA Regulation of Orthobiologics and the Shoulder Surgeon.

Issue Release: 2024

An Evaluation of First-in-Human Studies for RNA Oligonucleotides.

Issue Release: 2024

Chimeric Antigen Receptor T Cell Manufacturing on an Automated Cell Processor.

Issue Release: 2023

GMP-grade human neural progenitors delivered subretinally protect vision in rat model of retinal degeneration and survive in minipigs.

Issue Release: 2023

What is CRISPR Technology?

What are Genome Wide Association Studies (GWAS)?

What are GMOs?

What is Human Cloning?

Why is Cross Contamination a Concern in Biotechnology?

What Role Do Poplars Play in Phytoremediation?

How can ethical considerations mitigate economic disparity?

What are the Risks of Genetic Modifications?

Can Biotechnology Help in Managing Organic Pollutants?

How is Machine Learning Used in Personalized Medicine?

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