Pre-Clinical through Investigational New Drug Application (IND) 

• In the Topic dropdown on the FDA Guidance page, select ICH-Safety or Pharm/Tox    

• Drug Development Process     
• Clinical Trials and Human Subject Protection
• Phases of Human Clinical Trials         
• Drug Approval Process Infographic
• How to Request Single Patient Expanded Access
• A Guide to Non-Emergency Single Patient Expanded Access Submissions

• Enhanced Communication Team
• Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
• Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products   
• Engaging with FDA during New Drug Development Course         
• Pre-IND Meeting FAQs        
• Best Practices for Communication with FDA

• Exploratory INDs         
• Investigator-Initiated INDs and IND submission procedures         
• IND Exemptions         
• Expedited Programs

• Addresses for Submissions         
• Electronic Submissions        
• Drug Application Binders         
• Forms and Submission Requirements
• Reorganization of the Office of New Drugs
• Office of New Drugs Contacts

• Regulations: 21 CFR 314 and 21 CFR 601
• Inactive Ingredient Database
• Physician Labeling Rule (PLR)

• Deemed to be a License” Provision of the BPCI Act
• Transfer of Therapeutic Products to CDER 
• Therapeutic Biologic Applications (BLA) Approval Information

• Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
• Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products 
• Engaging with FDA during New Drug Development Course
• Advisory Committee meeting

• NDA Resources
• 505(b)(2) Applications 
• Prescription Drug User Fee Act (PDUFA)
• User Fee Waivers, Reduction, and Refunds for Drug and Biological Products
• Combination Products 

• Addresses for regulatory submissions
• Electronic Regulatory Submission and Review 
• Electronic Drug Registration and Listing
  • CDER Direct
• Drug Application Binders
• Forms and Submission Requirements
• Reorganization of the Office of New Drugs
• Office of New Drugs Contacts

• Activities Report of the Generic Drugs Program Monthly Performance
• Generic Drug Guidances 
• Referencing Approved Drug Products in ANDA Submissions Guidance for Industry
• Patent Certifications and Suitability Petitions
• Guidance for Industry: ANDA Submission - Content and Format of ANDAs
• Generic Drugs: Information for Industry
• ANDA Forms and Submissions Requirements

• GDUFA webpage
• GDUFA web-based learning courses
• Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance Guidance for Industry
• Self-Identification of Generic Drug Facilities, Sites and Organizations
• Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments
• Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry

• CDER Direct NextGen Collaboration Portal
  • CDER Direct NextGen Collaboration Portal FAQs
• Controlled Correspondence
• Electronic Regulatory Submission and Review
• Forms and Submission Requirements
• Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry
• Pre-ANDA Program
• Electronic Drug Registration and Listing Instructions
  • CDER Direct

• Guidance Documents for Generic Drugs (search Generics under topic)
• Orange Book
• Inactive Ingredient Database
• Import and Export of Human Drugs and Biologics
• Information for Exporters

• CDERLearn Course – Bringing OTC to Market
• Drug applications for OTC products
• Electronic Drug Registration and Listing Instructions
  • CDER Direct
• OTC Drug Product Review Process
• OTC Monographs
• Over-the-Counter Monograph User Fee Program (OMUFA)
• Webinar: Monograph reform is here! Learn what to expect and how to prepare - May 29, 2020

• Developing Products for Rare Diseases & Conditions
• Frequently Asked Questions About Therapeutic Biological Products
• Frequently Asked Questions (FAQ) About Designating an Orphan Product
• NIH Office of Rare Diseases Research
• Orphan Products Grants Program
• Rare Diseases Guidance Documents
• Search Orphan Drug Designations and Approvals

• FDA Adverse Event Reporting System (FAERS) Public Dashboard
• Drug Recalls
• Drug Safety Communications
• Drug Safety Guidance Documents
• Drug Safety Labeling Changes
• FDA Adverse Event Reporting System (FAERS)
• Medwatch
• Medwatch Form 3500A for Industry
• Risk Evaluation and Mitigation Strategies (REMS)

• Office of Prescription Drug Promotion (OPDP)
• Postmarketing Surveillance Programs

• Compliance Actions and Activities
• Unapproved Drugs

• Human Drug Compounding
• Compounding Risk Alerts
• Compounding and the FDA: Questions and Answers

• CGMP Guidance Documents (search under Pharmaceutical Quality/Manufacturing Standards (CGMP)
• CGMP Regulations
• Facts About CGMPs
• Inspections, Compliance, Enforcement, and Criminal Investigations
• Questions and Answers on CGMPs

• Drug Master File webpage
• Type II DMFs for Active Pharmaceutical Ingredients
• SBIA Webinar: New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know - February 4, 2016

• Drug Supply Chain Integrity
• Drug Supply Chain Security Act

• Export certificates
• Import and Export of Human Drugs and Biologics
• Information for Exporters

• Globalization
• Office of International Programs webpage

• Inspections, Compliance, Enforcement, and Criminal Investigations
• Office of Regulatory Affairs (ORA) Directory (PDF - 1 MB)

• Pharmaceutical Quality/CMC Guidances
• CGMP Guidance Documents (search under Pharmaceutical Quality/Manufacturing Standards (CGMP)
• Quality Metrics for Drug Manufacturing
• Drug Quality Sampling and Testing Programs
• Pharmaceutical Quality Resources 
   

• CDER Direct
• Drug Registration and Listing System
• Drug Establishments Current Registration

• Prescription Drug Labeling Resources – Labeling resources for the Prescribing Information, FDA-approved patient labeling, and carton and container labeling for human prescription drugs
• SBIA Prescription Drug Labeling Conference 2019
• SBIA Prescription Drug Labeling Conference 2017
• SBIA Prescription Drug Labeling Conference - Challenges and Issues 2015

• Drug Databases
• Laws, Regulations and Guidances
• Economic Assistance and Incentives for Drug Development
• FDA Forms
• Stay Informed with FDA Interactive Media
• Video and Transcript: FDA/CDER'€™s Small Business and Industry Assistance (SBIA)

• 2019 of Clinical Pharmacology Annual Report
• 2019 Division of Applied Regulatory Science Annual Report
• 2019 Office of Generic Drugs Annual Report
• 2019 Office of Pharmaceutical Quality Annual Report
• 2019 GDUFA Science and Research Report