Investigational New Drug (ind) Application - Vaccines

Relevant Publications

Regulatory Considerations for Producing mRNA Vaccines for Clinical Trials.

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

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

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

Issue Release: 2024

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

Issue Release: 2024

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

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

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

Issue Release: 2023

Automated Radiosynthesis of 1-(2-[ F]Fluoroethyl)-L-Tryptophan ([ F]FETrp) for PET Imaging of Cancer in Humans.

Issue Release: 2023

Modeling Approaches to Reimagine Stability (MARS) for Enabling Earlier Access to Critical Drugs for Patients with Unmet Medical Needs.

Issue Release: 2023

Fecal Microbiota Transplantation: History, Procedure and Regulatory Considerations.

Issue Release: 2023

Investigational New Drug Enabling Nonclinical Safety Pharmacology Assessment of the Iminosugar UV-4, a Broad-Spectrum Host-Targeted Antiviral Agent.

Issue Release: 2022

Preclinical safety assessment of toxicity and biodistribution of oncolytic virus HSV-1 expressing human PD-1 antibody in mice.

Issue Release: 2022

Ionizable liposomal siRNA therapeutics enables potent and persistent treatment of Hepatitis B.

Issue Release: 2022

Approaches for estimating the clinical starting dose of new dosage forms: An example of a long-acting injectable formulation of finasteride.

Issue Release: 2022

A randomized controlled pilot trial of etanercept and alpha-1 antitrypsin to improve autologous islet engraftment.

Issue Release: 2022

Preclinical development of an EP2 antagonist for post-seizure cognitive deficits.

Issue Release: 2022

Abstracts of Presentations at the Association of Clinical Scientists 143 Meeting Louisville, KY May 11-14,2022.

Issue Release: 2022

Rapidly Accelerated Development of Neutralizing COVID-19 Antibodies by Reducing Cell Line and CMC Development Timelines.

Issue Release: 2022

How is Post Marketing Surveillance Conducted?

What are the Goals of the Measles and Rubella Initiative?

What Should Healthcare Providers Consider When Vaccinating People with Diabetes?

What Diseases Do Childhood Vaccines Prevent?

How Can Social Media Be Used Positively?

What are T Cells?

Why are Vaccine Reporting Mechanisms Important?

Are There Any Side Effects of the Hepatitis B Vaccine?

How Can Communities Be Engaged Effectively?

How does the FDA ensure the safety of vaccines?

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