Confidential
IND Application - [Date]
[Sponsor-Investigator Name]
NOTES to Sponsor-Investigators:
- This template presents the sections that comprise the IND application. Guidance was
derived from FDA IND regulations, FDA guidance documents and ICH Good Clinical
Practice guidelines. Some of the wording in this template is taken directly from these
reference documents.
- For the purposes of this document, the term “drug” refers to both single drugs or biologics
and combination drugs/biologics that fall under the proposed IND application.
- It is required that each part of the IND be submitted in English.
- Model text for use in the application is in black text.
- Instructions and guidance are in [brackets] or italics.
- Delete instructions and guidance from the submitted application.
Investigational New Drug Application
Regulatory Sponsor:
Funding Sponsor:
Study Product:
Protocol Number:
Date:
Provide name of Sponsor-Investigator, department
name, address, and phone number during working
hours
Provide name of primary funding institution, address,
and phone number during working hours
Provide study drug name - generic, followed by trade
name(s), if applicable
Provide DF/HCC protocol number if available
Provide date submitted to FDA
Confidential
IND Application - [Date]
[Sponsor-Investigator Name]
Section 1.
FORM FDA 1571
Instructions and Guidance:
-
-
The current version of this form may be downloaded from the FDA web site at:
http://www.fda.gov/opacom/morechoices/fdaforms/cder.html
The Sponsor-Investigator signs the Form 1571.
The completed Form 1571 is submitted as Section 1.
Confidential
IND Application - [Date]
[Sponsor-Investigator Name]
Section 2.
TABLE OF CONTENTS
Instructions and Guidance:
- Volume numbers should be included in the table of contents if multiple volumes are used.
- Each major section should also have a table of contents.
- Sponsor-Investigators may provide information regarding the introductory statement and
investigational plan in a written cover letter.
- Add sub-sections to the table of contents as appropriate.
- A cross-reference letter or package insert may be submitted in lieu of required
information for sections: 3 (Introductory Statement and General Investigational Plan), 4
(Investigator’s Brochure), 6 (Chemistry, Manufacturing, and Control Data), 7
(Pharmacology and Toxicology Data), and 8 (Previous Human Experience).
- Remember to delete all instructions and guidance from the submitted application.
Section
Page
1.
FORM FDA 1571
2
2.
TABLE OF CONTENTS
3
3.
INTRODUCTORY STATEMENT AND GENERAL INVESTIGATIONAL
PLAN
3.1
4.
INVESTIGATOR’S BROCHURE (IB)
4.1
5.
PROTOCOL
5.1
5.2
5.3
6.
CHEMISTRY, MANUFACTURING, AND CONTROL DATA
6.1
6.2
7.
Study Protocol
Investigator and Facilities Information
Institutional Review Board Information
Environmental Exemption Claim
PHARMACOLOGY AND TOXICOLOGY DATA
7.1
8.
PREVIOUS HUMAN EXPERIENCE
8.1
9.
ADDITIONAL INFORMATION
9.1
9.2
DF/HCC Institutional Data and Safety Monitoring Plan
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IND Application - [Date]
[Sponsor-Investigator Name]
SECTION 3.
INTRODUCTORY STATEMENT AND GENERAL
INVESTIGATIONAL PLAN
Instructions and Guidance:
- The information in this section should place the developmental plan for the investigational
agent into perspective and allow FDA to anticipate your needs.
- This section should average 2-3 pages.
- Remember to delete all instructions and guidance from the submitted application.
Introductory Statement
Provide a brief summary of the objectives of the research plan(s) submitted in this IND
application. This should include a brief discussion of the disease state to be assessed.
[For studies referencing another IND and/or marketed products:]
Provide a brief statement that includes the name of the drug, and the name and address of the
manufacturer. The statement should contain a reference to the package insert or Letter of
Authorization to cross-reference another IND in order to address the requirements to identify the
drug, its active ingredients, structural formula and formulation.
Note: Append the package insert in section 4 (Investigator’s Brochure) if applicable. Append the
Letter of Authorization to cross-reference in section 9 (Additional Information).
Include a brief summary of the route of administration and planned exposure (e.g., duration of
study drug administration).
[For studies not using a cross-reference:]
Provide a brief introductory statement including the drug name, all active ingredients),
pharmacological class, structural formula (if known), formulation and dose, route of
administration, and planned exposure (e.g., duration of study drug administration).
Provide a high level summary of preclinical data to date including mechanism of action, efficacy
and safety. Content should be a brief synopsis of section 7 (Pharmacology and Toxicology Data).
Provide a high level summary of prior human experience with the investigational drug. Content
should be a brief synopsis of section 8 (Previous Human Experience). Include a statement about
whether the drug has been withdrawn from investigation or marketing in any country for reason
related to safety or efficacy. Cite the reason for the withdrawal.
General Investigational Plan
Discuss the rationale for the use of the drug and the specific study (ies).
Include the indication(s) to be studied, overall objectives, study design, estimated enrollment in
the trial, treatment plan, and anticipated risks based on preclinical and clinical experiences with
the drug.
Note: Indicate whether research plans are developed for the entire year.
3.1
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IND Application - [Date]
[Sponsor-Investigator Name]
INVESTIGATOR’S BROCHURE (IB)
SECTION 4.
Instructions and Guidance:
- Sponsor-Investigators are not required to submit an Investigator’s Brochure for a single
center study. An Investigator’s Brochure is required for multi-center studies.
A cross-reference letter or package insert may be submitted in lieu of required information
for the Investigator’s Brochure.
- The package insert may be found in the Physician’s Desk Reference, the FDA website, or
the United States Pharmacopoeia – National Formulary.
Remember to delete all instructions and guidance from the submitted application.
[For studies limited to DF/HCC:]
Include a statement that the IND meets the requirements for a Sponsor-Investigator single center
study, and that under the provisions of 21 CFR 312.55, an Investigator’s Brochure is not required.
[For multi-center studies referencing another IND and/or marketed products:]
Provide a brief statement that references the package insert or Letter of Authorization to crossreference another IND in order to address the requirements of an Investigator’s Brochure.
Notes: Append a copy of the package insert behind this page. Append the Letter of Authorization
to cross-reference in section 9 (Additional Information).
[For multi-center studies not using a cross-reference:]
Provide an Investigator’s Brochure. The outline below embodies the elements of an Investigator’s
Brochure according to Good Clinical Practice. For detailed guidance related to content of the
sub-sections, refer to the ICH Guidance for Good Clinical Practice. (See http://www.ich.org Efficacy Guidelines – E6.)
4.1
Title Page
4.2
Table of Contents
4.3
Summary
4.4
Introduction
4.5
Physical, Chemical, and Pharmaceutical Properties and Formulation
4.6
Nonclinical Studies
4.7
4.6.1
NonClinical Pharmacology
4.6.2
Pharmacokinetics and Product Metabolism in Animals
4.6.3
Toxicology
Effects in Humans
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4.7.1
Pharmacokinetics and Product Metabolism in Humans
4.7.2
Safety and efficacy
4.7.3
Marketing Experience
4.8
Summary of Data and Guidance for the Investigator
4.9
References
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IND Application - [Date]
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SECTION 5.
PROTOCOL
Instructions and Guidance:
- A separate title page should be included for each section.
- Delete any sub-section if not applicable.
- The study protocol should use the standard DF/HCC protocol format (see below).
- Remember to delete all instructions and guidance from the submitted application.
Section
Page
5.1
Study Protocol
5.1.1 Consent Form (if available)
5.2
Investigator and Facilities Information
5.2.1 Principal Investigator
5.2.2 Form FDA 1572
5.2.3 Principal Investigator Curriculum Vitae
5.2.4 Co-investigator Credentials
5.2.5 Form FDA 3454
5.2.6 Form FDA 3455 (if applicable)
5.2.7 Conflict of Interest Documentation (if applicable)
5.2.8 Form FDA 3674
5.3
Institutional Review Board Information
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IND Application - [Date]
[Sponsor-Investigator Name]
Instructions and Guidance:
- List all protocols by title on this face sheet in the order they are attached.
- Include copies of all protocols to be conducted under this IND application.
- Remember to delete all instructions and guidance from the submitted application.
5.1
Study Protocol
Insert Protocol(s)on next page.
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Instructions and Guidance:
- Insert the study protocol(s) at this point.
- Phase 1 studies should provide an outline of the investigation including a statement of the
objectives and purpose of the investigation, an estimate of subjects to be studied, a
description of safety exclusions, a description of dosing plan (duration, dose, method used
to determine dose), measures to ensure and evaluate subject safety (e.g., performance of
blood chemistries, and toxicity-based stopping or dose adjustment rules).
- Phase 2 and 3 protocols should include alternative plans to address anticipated deviations
(i.e. early crossover of non-responders to alternative therapy).
- Do not include the DF/HCC Institutional Data and Safety Monitoring Plan (DF/HCC DSMP)
in this section. A full version of the DF/HCC DSMP will appear in section 9 of this IND
application.
- Suggested content of the protocol as described by DF/HCC format is listed below.
- Remember to delete all instructions and guidance from the submitted application.
INDEX
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
11.0
12.0
13.0
14.0
15.0
16.0
17.0
SCHEMA
Objectives
Background
Participant Selection
Registration Procedures
Treatment Plan
Expected Toxicities and Dosing Delay/Dose Modifications
Drug Formulation and Administration
Correlative Studies
Study Calendar
Measurement of Effect
Adverse Event Reporting Requirements
Data and Safety Monitoring
Regulatory Consideration
Statistical Consideration
Publication Plan
References
Appendices
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Instructions and Guidance:
- List protocol title(s) for which consent forms are attached. List in the order they are
attached.
- Include copies of all consent forms for protocols noted in the protocol section.
- For gene therapy studies, the gene therapy component of the treatment and any
associated risks to the subject should be clearly identified in the consent form.
- Remember to delete all instructions and guidance from the submitted application.
5.1.1 Consent Form:
Insert Protocol Consent Form(s) on next page.
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Instructions and Guidance:
- Remember to delete all instructions and guidance from the submitted application.
5.2
Investigator and Facilities Information
5.2.1 Principal Investigator
The principal investigator for the protocol entitled “insert protocol name” is [name of PI].
His/Her office is located at:
Dana-Farber/Harvard Cancer Center
Name of Institution
Department of supply correct department name
Street Address, Building and room #
Boston, MA supply correct zip code
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Instructions and Guidance:
- The current version of this form may be downloaded from the FDA web site at:
http://www.fda.gov/opacom/morechoices/fdaforms/cder.html
- The Sponsor-Investigator signs the Form 1572.
- Remember to delete all instructions and guidance from the submitted application.
5.2.2 Form FDA 1572: Insert Form 1572 on next page.
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Instructions and Guidance:
- The Principal Investigator should sign and date the CV in the upper right corner.
- Remember to delete all instructions and guidance from the submitted application.
5.2.3 Principal Investigator Curriculum Vitae: Insert CV on next page.
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Instructions and Guidance:
- Each sub-investigator should sign and date the respective biosketch or CV in the upper
right corner.
- Remember to delete all instructions and guidance from the submitted application.
5.2.4 Co-Investigator Credentials: Insert sub-investigator credentials (i.e., biosketch or CV) on
the next page.
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Instructions and Guidance:
- The current version of this form may be downloaded from the FDA web site at:
http://www.fda.gov/opacom/morechoices/fdaforms/cder.html
- This form addresses financial arrangements and interests.
- The Sponsor-Investigator signs the Form 3454.
- Remember to delete all instructions and guidance from the submitted application.
5.2.5 Form FDA 3454: Insert Form 3454 on next page.
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IND Application - [Date]
[Sponsor-Investigator Name]
Instructions and Guidance:
- The current version of this form may be downloaded from the FDA web site at:
http://www.fda.gov/opacom/morechoices/fdaforms/cder.html
- This form discloses financial arrangements and interests.
- The Sponsor-Investigator signs the Form 3455.
- Remember to delete all instructions and guidance from the submitted application.
- Delete this section if not applicable.
5.2.6 Form FDA 3455: (if applicable, i.e., IRB has identified a conflict of interest)
Insert Form 3455 on next page.
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IND Application - [Date]
[Sponsor-Investigator Name]
Instructions and Guidance:
- Remember to delete all instructions and guidance from the submitted application.
- Delete this section if not applicable.
5.2.7 Conflict of Interest Documentation: (if applicable)
Insert copies of Institutional Letters from the appropriate liaison office on next page.
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IND Application - [Date]
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Instructions and Guidance:
- The current version of this form may be downloaded from the FDA website at:
http://www.fda.gov/opacom/morechoices/fdaforms/FAD-3674.pdf
- This form certifies that the sponsor-investigator has appropriately registered their trial(s) on
clinicaltrials.gov.
- Remember to delete all instructions and guidance from the submitted application.
- Delete this section if not applicable.
5.2.8 Form FDA 3674: Insert Form 3674 on next page.
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IND Application - [Date]
[Sponsor-Investigator Name]
Instructions and Guidance:
- Indicate if IRB approval is pending.
- For multi-center studies (more than one IRB of record), indicate the IRB approval status
for each research institution and provide the name and address of the corresponding IRB.
- Remember to delete all instructions and guidance from the submitted application.
5.3
Institutional Review Board (IRB) Information Insert documentation of IRB approval on
next page.
The protocol entitled “[insert protocol name]” select the appropriate text
has not been submitted to the local Institutional Review Board, however the approval letter
will be forwarded to FDA upon receipt.
Or
has been submitted to the local Institutional Review Board, and the approval letter is shown
on the next page.
The protocol [select best response: will be or was] reviewed by:
Dana-Farber Cancer Institute Institutional Review Board
450 Brookline Avenue, OS-229
Boston, MA 02215
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IND Application - [Date]
[Sponsor-Investigator Name]
SECTION 6.
CHEMISTRY, MANUFACTURING, AND CONTROL DATA
Instructions and Guidance:
The information in this section should assure the proper identification, quality, purity, and
strength of the investigational drug and provide information to evaluate drug safety.
A cross-reference letter or package insert may be submitted in lieu of required information
on chemistry, manufacturing, and control data.
- The package insert may be found in the Physician’s Desk Reference, the FDA website, or
the United States Pharmacopoeia – National Formulary.
- Remember to delete all instructions and guidance from the submitted application.
- Delete any sub-section if not applicable.
Section
6.1
6.2
6.3
6.4
6.5
6.6
6.7
Page
Letter of Authorization to Cross-Reference (if applicable)
Response to Gene Therapy Letter (if applicable)
Product Substance/Components (if applicable)
Final Product (if applicable)
Placebo Product (if applicable)
Labeling (if applicable)
Environmental Exemption Claim
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Instructions and Guidance:
6.1 Letter of Authorization to Cross-Reference [For studies referencing another IND and/or
marketed products]
Provide a brief statement that includes a reference to the package insert or Letter of Authorization
to cross-reference another IND in order to address the requirements for chemistry,
manufacturing, and control information.
Note: Append the package insert in section 4 (Investigator’s Brochure). Append the Letter of
Authorization to cross-reference in section 9 (Additional Information).
6.2
Response to Gene Therapy Letter [For gene therapy studies]
Information requested in the FDA’s March 6, 2000, Gene Therapy Letter should be provided as
part of the IND application. (See http://www.fda.gov/cber/ltr/gt030600.htm.)
Note: Responses to items 1-5 of the letter may be cross-referenced, if applicable. Responses to
item 6 of the letter may be addressed by the DF/HCC Institutional Data and Safety Monitoring
Plan included in section 9 of this IND application. Responses to item 7 of the letter may be
included in the cover letter that accompanies this IND application.
6.3
6.4
6.5
6.6
Product Substance/Components [For studies not using a cross-reference]
Final Product [For studies not using a cross-reference]
Placebo Product [For studies not using a cross-reference]
Labeling [For studies not using a cross-reference]
[For studies not using a cross-reference:]
Describe the composition, manufacture, and control of the bulk substance and final product.
Pertinent information includes the name and address of the manufacturer, methods of
manufacture, container/closure system(s), analytical methods, and stability testing. Additional
information may include descriptions of any placebo used in the clinical trial, and labeling to be
provided to investigators.
The amount of supporting information varies with the investigational phase and product used in
the clinical trial. For detailed information on the content of this section, refer to the appropriate
FDA guidance document.
Phase 1: FDA Guidance for Industry: Content and Format of Investigational New Drug
Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,
Biotechnology-derived Products. (See http://www.fda.gov/cder/guidance/phase1.pdf.)
Phase 2 and 3: FDA Guidance for Industry: INDs for Phase 2 and Phase 3 Studies: Chemistry,
Manufacturing, and Controls Information. (See http://www.fda.gov/cder/guidance/3619fnl.pdf.)
Gene Therapy: Draft Guidance for FDA Review Staff and Sponsors: Content and Review of
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy
Investigational New Drug Applications (INDs). (See http://www.fda.gov/cber/gdlns/gtindcmc.htm.)
6.7
Environmental Exemption Claim
Confidential
IND Application - [Date]
[Sponsor-Investigator Name]
Most drugs qualify for a categorical exclusion from an environmental assessment. The
categorical exclusion claim is a statement that the investigational product meets the
exclusion categories as not having a significant effect on the quality of the human
environment. The exclusion claim should include statements that: the action qualifies for
a categorical exclusion, with a citation to the regulations for the specific categorical
exemption claimed, and that to the applicant’s knowledge, no circumstances exist that
would warrant an environmental assessment.
[Sample text:]
In accordance with 21 CFR 25.30/25.31, [add Sponsor-Investigator name] requests a
categorical exclusion from the requirement for an environmental assessment for the
manufacture and formulation of [drug name] for use in human clinical trials. All waste
from the investigational anticancer drug(s) will be properly controlled. The amount of
waste expected to enter the environment may reasonably be expected to be nontoxic.
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IND Application - [Date]
[Sponsor-Investigator Name]
SECTION 7.
PHARMACOLOGY AND TOXICOLOGY DATA
Instructions and Guidance:
- The information in this section should present pharmacological and toxicological studies
that support the contention that the drug is reasonably safe for clinical investigations in
humans.
- The pharmacology information in this section should average 5 pages.
- The toxicology information in this section should average 10-15 pages of text with tables or
other visual presentation aids as appropriate.
A cross-reference letter or package insert may be submitted in lieu of required information
on pharmacology and toxicology data.
- The package insert may be found in the Physician’s Desk Reference, the FDA website, or
the United States Pharmacopoeia – National Formulary.
- Remember to delete all instructions and guidance from the submitted application.
[For studies referencing another IND and/or marketed products:]
Provide a brief statement that references the package insert or Letter of Authorization to crossreference another IND in order to address the requirements for available pharmacology and
toxicology data.
Notes: Append a copy of the package insert in section 4 (Investigator’s Brochure). Append the
Letter of Authorization to cross-reference in section 9 (Additional Information).
[For gene therapy studies:]
Add the following statement where appropriate: Animal safety information provided to [add
Sponsor-Investigator name] has been submitted as described in 21 CFR 312.32-33.
[For studies not using a cross-reference:]
Describe the pharmacological effects and mechanism of action in animals, pharmacokinetics
(absorption, distribution, metabolism, excretion), and toxicological effects in animals and in vitro.
The outline below embodies the elements of pharmacology/toxicology reviews. For detailed
guidance related to content of the sections, refer to the FDA guidance for
Pharmacology/Toxicology review Format. (See http://www.fda.gov/cder/guidance//4120fnl.pdf).
7.1
Pharmacology
7.2
Safety Pharmacology
7.3
Pharmacokinetics
7.4
Pharmacology Summary
7.5
Pharmacology Conclusions
7.6
Toxicology
7.7
Genetic Toxicology
7.8
Carcinogenicity
7.9
Reproductive and Developmental Toxicology
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7.10
Special Toxicity Studies
7.11
Toxicology Summary
7.12
Toxicology Conclusions
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IND Application - [Date]
[Sponsor-Investigator Name]
SECTION 8.
PREVIOUS HUMAN EXPERIENCE
Instructions and Guidance:
- Regulations require this section if there has been previous human experience with the
drug. If there is no experience, that information should be reflected in the application.
A cross-reference letter or package insert may be submitted in lieu of required information
on previous human experience.
- The package drug may be found in the Physician’s Desk Reference, the FDA website, or
the United States Pharmacopoeia – National Formulary.
- Remember to delete all instructions and guidance from the submitted application.
- Delete any sub-section if not applicable.
[For studies referencing another IND and/or marketed products:]
Provide a brief statement that references the package insert or Letter of Authorization to crossreference another IND in order to address the requirements for information regarding previous
human experience.
Notes: Append a copy of the package insert in section 4 (Investigator’s Brochure). Append the
Letter of Authorization to cross-reference in section 9 (Additional Information).
[For studies not using a cross-reference:]
Summarize any relevant clinical information available. The sub-sections below should be
considered.
8.1 Marketed Experience
Provide marketed indications for the study drug either in the US or abroad. If the drug was
withdrawn from the market for any reason related to safety or effectiveness, identify the
country (ies) where the drug was withdrawn and the reasons for withdrawal.
8.2 Clinical Research Experience
Summarize results from any clinical trials using the investigational drug. Include published
research and any available unpublished research that relates to the safety and efficacy of the
investigational drug or the rationale of the proposed trial. Attach full reprints for highly
relevant publications. Supply a bibliography for lesser relevant publications.
8.3 Off-Label Experience
If available, indicate any published literature on the safety of the drug used in clinical care
settings to treat patients for indications that do not have FDA approval, published practice
guidelines of the use of the drug for standard-of-care, and any associated safety information.
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SECTION 9.
ADDITIONAL INFORMATION
Instructions and Guidance:
- Supply additional information if it is applicable to the investigational drug and/or study.
- The full DF/HCC Institutional Data and Safety Monitoring Plan (DSMP) may be
downloaded from the QACT web site at:
http://www.dfhcc.harvard.edu/clinical-research-support/quality-assurance-office-for-clinicaltrials-qact/policies-and-procedures/.
- Remember to delete all instructions and guidance from the submitted application.
- Delete any sub-section if not applicable.
9.1
DF/HCC Institutional Data and Safety Monitoring Plan (DSMP)
Attach the DSMP behind this page.
9.2
Letter of Authorization to Cross-Reference (if applicable)
Attach the letter behind this page.
9.3
Certificate of Analysis (if applicable)
Attach the letter behind this page.
9.4
Container Label(s) (if applicable)
Attach the letter behind this page.
9.5
[Add any additional pertinent information not already included in other sections,
such as drug dependence and abuse potential, radioactive drugs, pediatric safety
and efficacy studies, or other information that would aid in the evaluation of the
safety or design of the clinical investigation.]
Attach any additional pertinent information not already included in other sections
behind this page.
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Additional Instructions and Guidance on Submitting and Processing an IND:
- After the IND information is compiled, the final formatting and processing begins.
- Remember to delete the next two pages from the submitted application.
Paper Size
U.S. standard paper size (8-1/2 by 11 inches) is preferred.
Page Numbering
Pages are numbered in sequential order. The page number should be accurately reflected in the
table of contents (IND Section 2). There should also be a table of contents for each item section
within the IND with the correct page numbering listed.
Number of Copies
An original and two copies of the IND application are submitted to the FDA.
Section Dividers
Include tabs prior to the first page of each section number in the IND and the table of contents to
facilitate navigation through the IND.
.
Numbering of IND Submissions
The initial IND application is numbered 0000, and each subsequent correspondence submission
is chronologically numbered.
Address for IND Submissions
Consult the FDA web site (http://www.fda.gov), or contact them toll free at 1-888-INFOFDA to
confirm the current address for submission of an IND application.
Binding and Delivery Procedures
The Centers within the FDA do not have universal binding or delivery procedures. Consult the
appropriate document center to confirm the current practices regarding regulatory document
submission.
In general the investigator should:
- Maintain a 1.5-inch left margin and 1-inch margin on the top, right and bottom to assure
text will not be obscured in the fastened area.
- Submit the appropriate number of copies.
- Clearly indicate the original archive copy, and the duplicate copies.
- Include a cover letter that clearly identifies the type of submission and appropriate
application number.
- Submit all documents through the appropriate document center.
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Template References:
21 CFR 312.23
Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry,
Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New
Drug Applications (INDs). FDA web site: http://www.fda.gov/cber/gdlns/gtindcmc.htm
FDA Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs)
for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived
Products. FDA web site: http://www.fda.gov/cder/guidance/phase1.pdf
FDA Guidance for Industry: INDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing,
and Controls Information. FDA web site address: http://www.fda.gov/cder/guidance/3619fnl.pdf
FDA Guidance for Reviewers: Pharmacology/Toxicology Review Format. FDA web site address:
http://www.fda.gov/cder/guidance/4120fnl.pdf
FDA’s
March
6,
2000,
Gene
http://www.fda.gov/cber/ltr/gt030600.pdf
Therapy
Letter.
FDA
web
site
address:
International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice E6. ICH
web site address: http://www.ich.org