Introduction
       Good communications between FDA and the industries it regulates are 
       key to successful product development and promoting an 
       understanding of the regulation process and regulatory compliance.
       Understanding the various types of communications and meetings, 
       their purposes, formats and timelines is critical to the success of 
       regulatory professionals and the organizations they represent and is 
       vital if they are to achieve their desired objectives in the most efficient 
       and effective way.
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                Types of FDA Communications
         Four basic types of regulatory interactions apply to drugs, biologics and devices:
            1)    regulatory communications
            2)product application meetings
            3)administrative meetings and communications
            4)public administrative proceedings
         Significant guidances issued by FDA address the above interactions.  They describe for 
          sponsors when and how to request and execute the various administrative communications 
          and meetings.  Following the published guidances has numerous benefits, such as:
            • Design testing and development plans that will expedite reviews and approvals
            • Saving sponsors time and money
            • Providing a more collaborative approach
            • Significantly reducing the possibilities of development surprises  
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                      Regulatory Communications
         21 CFR 10 (Administrative Practices and Procedures) – governs practices and procedures for preparing 
           and communicating FDA regulations, guidances and recommendations.
            Regulations:
            • with limited exceptions, regulations are published in the Federal Register
            • available for public comment and are generally subject to a 60 day comment period
            Guidance Documents:
            • describe FDA’s current thinking on a topic
            • should be viewed only as a recommendation unless specific regulatory or statutory requirements are 
             cited
            • differ from a regulation because they are non-binding (not legally enforceable) on FDA or the public
            Recommendations:
            •  FDA’s advice on specific regulatory policy
            •  Disseminated in the Federal Register or via emails to a specific audience
            •  Provide specific advice that does not involve direct regulatory action under law
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         Regulatory Communications (Continued)
       Three (3) Types of Regulatory Communications – Citizen Petitions, Suitability Petitions and Advisory Opinion
         1.  Citizen Petitions:
           • A formal written request to FDA asking to take or refrain from taking an administrative action
           • FDA must respond within 180 days of receipt
           • Petition should contain:  action requested, statement of grounds, environmental impact, economic 
            impact and a certification by the submitter
         2.  Suitability Petitions: 
           • Specific type of citizen’s petition used to file an abbreviated application for new human or animal 
            drug whose active ingredients, route of administration, dosage form or strength differ from that 
            of the approved drug
           • FDA will approve or deny a suitability petition within 90 days of submission date
         3.  Advisory Opinion:
           • FDA’s formal position on a matter
           • FDA statements of policy, such as the preamble to a final rule or the Compliance Policy Guides 
            Manual, constitute advisory opinions
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              Product Application Meetings
       
       Three (3) main types of product application meetings for pharmaceuticals and biologics:  Type A, Type 
       B and Type C (Guidance for Industry:  Formal Meetings Between the FDA and Sponsors or Applicants)
       •
       communications and meetings are requested at critical product development points to establish or 
       confirm that a company’s product development plan will lead to an FDA marketing approval.
       •
       application meetings requested by sponsor and are private, two-way communications (either by phone 
       or in person) between FDA and the sponsor
       •
       meetings follow a systematic approach and well-established FDA procedures
       •
       FDA Guidance advises notifying appropriate review division CDER or CBER prior to submitting an 
       official request for all types of meetings
       •
       official meeting requests should be submitted to the appropriate review division in writing and should 
       include a complete listing of questions the sponsor wishes to address or resolve
       •
       clearly explain the rationale for the request and the issues to be discussed
       •
       FDA reserves the right to grant or deny Type A, B or C meeting requests
       •
       If denied FDA will include an explanation for the denial; notification from FDA for Type A meetings 
       usually occur within 14 days and within 21 days for Types B and C
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