📋 FDA Submission Template for Vault Protein Therapies

1. Cover Letter Template

[Date]

Division of [Appropriate Division]
Center for Drug Evaluation and Research
Food and Drug Administration
[Address]

Subject: Investigational New Drug Application for [Vault Protein Therapy Name]

Dear [Division Director],

We are submitting an Investigational New Drug (IND) application for [Vault Protein Therapy Name], a novel vault protein-based therapeutic for the treatment of [disease/condition].

This submission includes:
- Form FDA 1571
- Form FDA 1572
- Investigator's Brochure
- Clinical Protocol
- Chemistry, Manufacturing, and Controls (CMC) information
- Pharmacology and Toxicology data
- Previous human experience (if applicable)

We request a 30-day review period and are available for any questions or requests for additional information.

Sincerely,

[Name]
[Title]
[Institution/Company]
[Contact Information]

2. Form FDA 1571 Template

Section A: Sponsor Information

• Sponsor Name: [Your Institution/Company]
• Address: [Complete Address]
• Contact Person: [Name and Title]
• Phone: [Phone Number]
• Email: [Email Address]

Section B: Drug Information

• Drug Name: [Vault Protein Therapy Name]
• Generic Name: [If applicable]
• IND Number: [If previously assigned]
• Drug Class: Vault Protein Therapeutic
• Route of Administration: [Intravenous/Intratumoral/etc.]
• Dosage Form: [Solution/Suspension/etc.]

Section C: Application Type

• New IND: ☑
• Amendment: ☐
• Information Amendment: ☐

3. Investigator's Brochure Template

3.1 Drug Description

Drug Name: [Vault Protein Therapy Name]
Generic Name: [If applicable]
Chemical Name: [Vault protein construct description]
Molecular Weight: [13 MDa for vault particle]
Structure: [Include structural information]

3.2 Mechanism of Action

Vault proteins are naturally occurring nanoparticles that can be engineered to deliver therapeutic payloads with high precision. The mechanism of action involves:

• Targeted delivery to specific cell types
• Controlled release of therapeutic payloads
• Minimal off-target effects
• Enhanced bioavailability and stability

4. Chemistry, Manufacturing, and Controls (CMC)

4.1 Manufacturing Process

• Expression system and host cell line
• Purification methods and quality control
• Characterization of final product
• Stability testing protocols

4.2 Quality Control

• Identity testing
• Potency assays
• Purity and impurity analysis
• Sterility and endotoxin testing

5. Pharmacology and Toxicology

5.1 Preclinical Studies

• In vitro pharmacology studies
• Animal toxicology studies
• Pharmacokinetic analysis
• Safety pharmacology

5.2 Safety Assessment

• Acute and chronic toxicity
• Genotoxicity studies
• Reproductive toxicity (if applicable)
• Carcinogenicity studies (if required)