Drug Approval Application Process

The following resources have been gathered to provide you with the legal requirements of drug applications, assistance from CDER to help you meet those requirements, and internal review principles, policies and procedures.

Drug Approval Application Process

• Main Drug Approval Application Page

Over-the-counter (OTC) Drug Products

• Office of Nonprescription Products
• OTC-Related Federal Register Notices, Ingredient References, and other Regulatory Information
• Rulemaking History for Nonprescription Products: Drug Category List
• OTC Cough/Cold Drug Products
• Compliance Policy Guide 7132b.15: Drugs - General Provisions and Administrative Procedures for Recognition as Safe and Effective
• Compliance Policy Guide 7132b.16: OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products
• FDA’s Dockets Management Site - for access to public comments submitted regarding development of OTC monographs

Chemistry, Manufacturing, and Controls

• Compliance with Current Good Manufacturing Practice (CGMP) regulations
• CGMP Guidances
• List of Drug Master Files (DMF) holders
• Microbiology: Guideline for the format and content of the Microbiology Section of an application

Abbreviated New Drug Application (ANDA)

• Abbreviated New Drug Application (ANDA) Process for Generic Drugs
• Office of Generic Drugs
• Electronic Orange Book:  Approved Drug Products with Therapeutic Equivalence Evaluations

New Drug Application (NDA)

• New Drug Application (NDA) Process
• Form 356h: Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use
• New Requirements for Prescribing Information
• Guidance: Applications Covered by Section 505(b)(2)
• Response to Citizen Petitions regarding Section 505(b)(2)
• Organizational Chart of the CDER Office of New Drugs
• Guidance: Formal Meetings with Sponsors and Applicants for PDUFA Products
• Guidance: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products

Investigational New Drug (IND) Application

• Investigational New Drug (IND) Application Process

Demonstrating Clinical Drug Safety

• Guidance:  Premarketing Risk Assessment

Pediatric Considerations

• Guidance: Qualifying for Pediatric Exclusivity
• Guidance: How to Comply with the Pediatric Research Equity Act

User Fees and Waivers

• Prescription Drug User Fee Act (PDUFA) Documents on CDER site
• FDA Prescription Drug User Fees Act (PDUFA) Page
• PDUFA Guidance Documents

Small Business

• Small Business Assistance

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Date created: March 13, 2007, updated November 23, 2007

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