Information for Industry | Drugs

Search databases for regulatory information on all aspects of the drug development and approval process, submit drug applications, pay user fees, get small business assistance.

Guidances related to drugs

Documents representing FDA's current thinking on a particular subject

Search FDA Guidances

Drug Approvals and Databases

Approvals and medications—Drugs@FDA, FDALabel, Orange Book, and more

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Development and Approval Process

Drug applications, submissions, manufacturing, and small business help

CDER Small Business and Industry Assistance

Human drug development and regulation, conferences, webinars, training courses, and more

Advisory Committees

Independent opinions and recommendations from outside experts on applications to market new drugs and on FDA policies

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Topic

Webpage	Topic
About FDA	About FDA and CDER
CDER Ombudsman	About FDA and CDER
Doing Business With FDA	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