CDER Small Business & Industry Assistance (SBIA)
Drug Development
Pre-Clinical through Investigational New Drug Application (IND)Clinical Trials
Drug Development Process
Clinical Trials and Human Subject Protection
Phases of Human Clinical Trials
Drug Approval Process Infographic
Drug Development Process
Clinical Trials and Human Subject Protection
Phases of Human Clinical Trials
Drug Approval Process Infographic
Engaging with FDA
Enhanced Communication Team
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
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
Enhanced Communication Team
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
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
IND Submissions
Exploratory INDs
Investigator-Initiated INDs and IND submission procedures
IND Exemptions
Expedited Programs
Exploratory INDs
Investigator-Initiated INDs and IND submission procedures
IND Exemptions
Expedited Programs
Regulatory Submissions
Addresses for Submissions
Electronic Submissions
Drug Application Binders
Forms and Submission Requirements
Addresses for Submissions
Electronic Submissions
Drug Application Binders
Forms and Submission Requirements
New Drug Application(NDA)/Biologic License Application (BLA)
Submission of the Marketing ApplicationResources
Regulations: 21 CFR 314 and 21 CFR 601
Inactive Ingredient Database
Physician Labeling Rule (PLR)
Regulations: 21 CFR 314 and 21 CFR 601
Inactive Ingredient Database
Physician Labeling Rule (PLR)
Therapeutic Biologics
Transfer of Therapeutic Products to CDER
Therapeutic Biologic Applications (BLA) Approval Information
Transfer of Therapeutic Products to CDER
Therapeutic Biologic Applications (BLA) Approval Information
Meetings
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Engaging with FDA during New Drug Development Course
Advisory Committee meeting
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Engaging with FDA during New Drug Development Course
Advisory Committee meeting
ANDA Submission Requirements
Guidance for Industry: ANDA Submission - Content and Format of ANDAs
Generic Drugs: Information for Industry
ANDA Filing Checklist
ANDA Forms and Submissions Requirements
Guidance for Industry: ANDA Submission - Content and Format of ANDAs
Generic Drugs: Information for Industry
ANDA Filing Checklist
ANDA Forms and Submissions Requirements
GDUFA
GDUFA webpage
GDUFA web-based learning courses
Guidance for Industry: GDUFA 2012 Questions and Answers
Self-Identification of Generic Drug Facilities, Sites and Organizations
GDUFA webpage
GDUFA web-based learning courses
Guidance for Industry: GDUFA 2012 Questions and Answers
Self-Identification of Generic Drug Facilities, Sites and Organizations
Communications and Electronic Submissions
Controlled Correspondence
Electronic Regulatory Submission and Review
Forms and Submission Requirements
Electronic Drug Registration and Listing Instructions
CDER Direct
Controlled Correspondence
Electronic Regulatory Submission and Review
Forms and Submission Requirements
Electronic Drug Registration and Listing Instructions
CDER Direct
Biosimilars Guidances
Biosimilar User Fee Act (BsUFA)
Biosimilars Webpage for Industry
FDA Webinar - FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the US
Frequently Asked Questions About Therapeutic Biological Products
Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
What are Biosimilar Products?
Biosimilar User Fee Act (BsUFA)
Biosimilars Webpage for Industry
FDA Webinar - FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the US
Frequently Asked Questions About Therapeutic Biological Products
Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
What are Biosimilar Products?
Current Good Manufacturing Practices (CGMPs)
CGMP Guidance Documents
CGMP Regulations
Facts About CGMPs
Inspections, Compliance, Enforcement, and Criminal Investigations
Questions and Answers on CGMPs
CGMP Guidance Documents
CGMP Regulations
Facts About CGMPs
Inspections, Compliance, Enforcement, and Criminal Investigations
Questions and Answers on CGMPs
Import/Export
Export certificates
Import and Export of Human Drugs and Biologics
Information for Exporters
Export certificates
Import and Export of Human Drugs and Biologics
Information for Exporters
Office of Regulatory Affairs
Inspections, Compliance, Enforcement, and Criminal Investigations
Office of Regulatory Affairs (ORA) Directory
Inspections, Compliance, Enforcement, and Criminal Investigations
Office of Regulatory Affairs (ORA) Directory
Registration and Drug Listing
CDER Direct
Drug Registration and Listing System
Drug Establishments Current Registration
CDER Direct
Drug Registration and Listing System
Drug Establishments Current Registration
Resources for You
Can’t find what you are looking for? Contact the CDER SBIA staff
(866) 405-5367
(301) 796-6707
CDER SBIA
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
Follow us on LinkedIn
to stay connected!
Subscribe
Sign up to receive email updates from CDER SBIA