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US FDA Guidelines

United States Food and Drug Administration - Comprehensive guidance for drug approval in the world's largest pharmaceutical market.

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10-12

Months NDA Review

$3.2M+

PDUFA User Fee

eCTD

Submission Format

CDER/CBER

Review Centers

Submission Workflows: NDA vs ANDA

FDA Drug Approval Pathways

Compare the regulatory pathways for new drug applications (NDA) and abbreviated new drug applications (ANDA) for generic drugs

Step 1: Pre-IND Meeting

30-60 days for scheduling

Optional meeting with FDA to discuss development plans, study designs, and regulatory strategy before filing IND.

Submit meeting request with briefing document
Discuss CMC, nonclinical, and clinical plans
Receive written FDA feedback

Step 2: IND Submission

30-day review period

File Investigational New Drug application to begin clinical trials in the United States.

CMC information (Module 3)
Pharmacology/toxicology data (Module 4)
Clinical protocol and investigator information
Previous human experience if any

Step 3: Phase 1-3 Clinical Trials

6-10 years typically

Conduct clinical trials from first-in-human through pivotal efficacy studies.

Phase 1: Safety and dosing (20-100 subjects)
Phase 2: Efficacy signals and dose-response (100-500)
Phase 3: Pivotal efficacy trials (1000-5000+)
End-of-Phase meetings recommended

Step 4: Pre-NDA Meeting

2-4 months before NDA

Meeting with FDA to discuss NDA submission format, content, and any outstanding issues.

Discuss data package completeness
Clarify any outstanding FDA concerns
Confirm submission format and e-CTD specs

Step 5: NDA Submission

Preparation: 6-12 months

Submit complete New Drug Application with all Modules 1-5 per eCTD format.

Complete eCTD with Modules 1-5
PDUFA user fee payment
Environmental assessment or exclusion
Patent certifications and exclusivity claims

Step 6: FDA Filing Review

60-day filing review

FDA conducts preliminary review to determine if application is complete for filing.

Refuse to file if major deficiencies
Filing means review clock starts
Day 74 letter confirms filing date

Step 7: Substantive Review

Standard: 12 months / Priority: 8 months

FDA conducts detailed scientific review of all submission components.

Clinical, CMC, and nonclinical reviews
Advisory Committee meeting if needed
Pre-approval inspection
Labeling negotiations

Step 8: FDA Action

PDUFA goal date

FDA issues Complete Response Letter or Approval Letter by PDUFA goal date.

Approval Letter: Marketing authorized
Complete Response Letter: Additional data needed
Approvable/Not Approvable rare outcomes

Reference Documents

FDA Guidance: Content and Format of INDs

Detailed guidance on IND submission requirements

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FDA Guidance: Bioequivalence Studies

Guidance for industry on BE study design and evaluation

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Key Regulations

21 CFR Part 314

Applications for FDA Approval to Market a New Drug

21 CFR Part 210/211

Current Good Manufacturing Practice

21 CFR Part 312

Investigational New Drug Application

ICH E6(R3)

Good Clinical Practice

Orange Book

Approved Drug Products with Therapeutic Equivalence Evaluations

Purple Book

Lists of Licensed Biological Products

Submission Types

New Drug ApplicationNDA
Abbreviated NDAANDA
Biologics LicenseBLA
Investigational DrugIND
505(b)(2) Application505(b)(2)
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