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          Resources for Foreign Pharmaceutical Regulatory AuthoritiesCDER International Program Resources for Foreign Pharmaceutical Regulatory Authorities
  
  	
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Overview of FDA Review Process for Investigational New Drugs
	Overview of FDA’s Regulatory Review and Research ActivitiesFDA Review Processes

Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications
	Biosimilar Biological Products
	Abbreviated New DrugsTechnical Standards

Electronic Common Technical Document
	Electronic Transmission of Individual Case Safety Reports Implementation Guide (E2B(R3))Searchable database for FDA Guidance documents:

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Training for ICH GuidelinesFor more information contact: CDERINTLEXEC@fda.hhs.gov

                                                                                  Content current as of:
      03/26/2020CDER International Program

          
                        International Regulatory Harmonization
          International Agreements & Information Sharing
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          Resources for Foreign Pharmaceutical Regulatory Authorities
 
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