About FDA |
About FDA and CDER |
CDER Ombudsman |
About FDA and CDER |
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About FDA and CDER |
CDER Exclusivity Board |
About FDA and CDER |
Jobs at FDA |
About FDA and CDER |
Phonetic and Orthographic Computer Analysis (POCA) Program |
Application Forms, Submission Requirements & User Fees |
Investigational New Drug (IND) Application |
Application Forms, Submission Requirements & User Fees |
New Drug Application (NDA) |
Application Forms, Submission Requirements & User Fees |
Abbreviated New Drug Application (ANDA) |
Application Forms, Submission Requirements & User Fees |
Patent Certifications and Suitability Petitions |
Application Forms, Submission Requirements & User Fees |
Therapeutic Biologics Applications (BLA) |
Application Forms, Submission Requirements & User Fees |
Drug Applications for Over-the-Counter (OTC) Drugs |
Application Forms, Submission Requirements & User Fees |
User Fees (BsUFA, GDUFA, OMUFA, PDUFA) |
Application Forms, Submission Requirements & User Fees |
Electronic Regulatory Submission and Review |
Application Forms, Submission Requirements & User Fees |
CDER Data Standards Program |
Application Forms, Submission Requirements & User Fees |
Drugs@FDA |
Approvals and Databases |
FDALabel |
Approvals and Databases |
Orange Book |
Approvals and Databases |
Drug Approvals and Databases |
Approvals and Databases |
Acronyms and Abbreviations Search |
Approvals and Databases |
CDER Direct: Electronic Submissions Portal |
Approvals and Databases |
CDER Small Business and Industry Assistance (SBIA) |
CDER Small Business and Industry Assistance |
CDER SBIA Learn: Webinars, Conferences & Trainings |
CDER Small Business and Industry Assistance |
Development & Approval Process |
Development and Approval Process |
Advisory Committees (human drugs) |
Development and Approval Process |
Generic Drugs: Information for Industry |
Development and Approval Process |
Patent Certifications and Suitability Petitions |
Development and Approval Process |
Biosimilars |
Development and Approval Process |
Biomarker Qualification Program |
Development and Approval Process |
Developing Products for Rare Diseases and Conditions |
Development and Approval Process |
Expanded Access: Information for Industry |
Development and Approval Process |
USP Monograph Modernization Program |
Development and Approval Process |
CDER Data Standards Program |
Development and Approval Process |
Phonetic and Orthographic Computer Analysis (POCA) Program |
Development and Approval Process |
CDER Small Business & Industry Assistance (SBIA) |
Development and Approval Process |
Guidance, Compliance, and Regulatory Information |
Guidance, Compliance & Regulatory Information |
Guidances (Drugs) |
Guidance, Compliance & Regulatory Information |
Warning Letters and Notice of Violation Letters to Pharmaceutical Companies |
Guidance, Compliance & Regulatory Information |
Prescription Drug Labeling Resources |
Guidance, Compliance & Regulatory Information |
Drug Safety and Availability |
Information, Safety, and Availability |
Postmarket Drug Safety Information for Patients and Providers |
Information, Safety, and Availability |
Phonetic and Orthographic Computer Analysis (POCA) Program |
Information, Safety, and Availability |
Pharmaceutical Quality Resources |
Quality and Manufacturing |
Drug Supply Chain Security Act |
Quality and Manufacturing |
Report a Product Quality Issue |
Quality and Manufacturing |
Division of Drug Information (DDI) Webinars |
Training and Education |
FDA Drug Info Rounds A series of training videos for practicing clinical and community pharmacists |
Training and Education |
Truthful Prescription Drug Advertising and Promotion (Bad Ad Program) |
Training and Education |
CDERLearn Training and Education |
Training and Education |