• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

For Industry

  • Print
  • Share
  • E-mail

Enhanced Communication

Under PDUFA V the FDA promotes innovation through enhanced communication between FDA and sponsors during drug development (see PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017 - PDF 130KB).

FDA’s philosophy is that timely interactive communication with sponsors during drug development is a core activity to help achieve our mission to facilitate the conduct of efficient and effective drug development programs, which can enhance public health by making new safe and effective drugs available to the American public in a timely manner. 


Center for Biologics Evaluation and Research (CBER)

Enhanced communication contact information if your application is reviewed in CBER:
Please contact the Manufacturers Assistance and Technical Training Branch by phone at 1-800-835-4709 or 301-827-1800, or via e-mail at industry.biologics@fda.hhs.gov


Center for Drug Evaluation and Research (CDER)


 

What’s not changing?

The Regulatory Project Manager (RPM) remains the primary contact for application-specific, technical, and scientific questions (see Contact Information).

The RPM is a co-leader of the review team and has knowledge of the drug class, its history and related matters. The RPM is the primary resource to negotiate the timely resolution of technical, scientific, and regulatory questions, conflicts, or problems.

Please allow a reasonable amount of time for the RPM to respond to your contact attempts. If the RPM does not respond in a reasonable amount of time or within the expected timeframe for a regulatory submission, you should then follow-up with other review division management (e.g., Chief Project Management Staff first, then Deputy Division Director or Division Director, as needed). 
 

What's new?

The Enhanced Communication Team:

  • Is a point of for general questions about the drug development process or for clarification on which review division to contact with questions. The information you are looking for may also be available on the FDA website.

       Examples:

      • Where on the FDA website can I find guidance on electronic submissions?
      • What is the mailing address for regulatory submissions?
      • Which Review Division should I submit an IND to for an inhaled insulin product?
      • Whom should I contact to request a pre-IND meeting for a drug being developed for the treatment of MS?
         
  • Is a secondary point of communication for sponsors who are encountering problems in communicating with the review team for their IND. 

    Prior to contacting the Enhanced Communication team, allow a reasonable amount of time for the Review Division to respond.

       Examples:

      • When you have not received a response to a request within a reasonable timeframe.
      • When you have not received a response in the expected timeframe to a special protocol assessment or meeting request.
      • When you have not received a response to a simple or clarifying question or been referred to the formal meeting process within 30 days.

The Enhanced Communication Team assists in evaluating the issues to determine appropriate next steps, and then works with the review team and the sponsor to facilitate resolution of the problem.

  • Identifies and disseminates best practices for enhanced communication.

       Example:

      • Establishing clear expectations and agreement on appropriate mechanisms (e.g., when teleconferencing or secure email may be the most appropriate means of communication) and frequency of such communications.
         

You may contact the Enhanced Communication Team by emailing ONDEnhancedComm@fda.hhs.gov or by calling (301)-796-0319. Please provide the following applicable information when you contact the team:

  • Dates of the communications with the Review Division or Office
  • The subject of the communication with the Review Division or Office
  • Name of the Review Division or Office
  • Application number
  • Method of submission: email, phone, formal submission dated DD/MM/YYYY (include the names of those contacted by email or phone)
     

Contact Information             
 

Office of Drug Evaluation I (ODE I)   
    Division of Neurology Products (DNP) 301-796-2250         
    Division of Psychiatry Products (DPP) 301-796-2260
    Division of Cardiovascular and Renal Products (DCRP) 301-796-2240 
 
Office of Drug Evaluation II (ODE II) 
 
    Division of Metabolic and Endocrine Products (DMEP) 301-796-2290 
    Division of Pulmonary, Allergy and Rheumatology Products (DPARP) 301-796-2300 
    Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) 301-796-2280  

Office of Drug Evaluation III (ODE III) 
 
    Division of Gastroenterology and Inborn Errors Products (DGIEP) 301-796-2120    
    Division of Reproductive and Urologic Products (DRUP) 301-796-2130 
    Division of Dermatology and Dental Products (DDDP) 301-796-2110 

Office of Drug Evaluation IV (ODE IV)
  
 
    Division of Nonprescription Clinical Evaluation (DNCE) 301-796-2080 
    Division of Medical Imaging Products (DMIP) 301-796-2050

Office of Antimicrobial Products (OAP)
 
    Division of Anti-Infective Products (DAIP) 301-796-1400   
    Division of Anti-Viral Products (DAVP) 301-796-1500 
    Division of Transplant and Ophthalmology Products (DTOP) 301-796-1600      

Office of Hematology Oncology Products (OHOP)
  
 
    Division of Oncology Products I (DOP1) 301-796-2330 
         Breast, Gynecologic, Genitourinary,  
         Supportive care (non-hematologic)  
    Division of Oncology Products II (DOP2)  301-796-2320       
         Gastrointestinal, Lung/Head & Neck,   
         Neuro-oncology/Rare cancers/Pediatric Solid Tumor,  
         Melanoma/Sarcoma 
    Division of Hematology Products (DHP)    301-796-7550
         Benign hematology, Hematologic malignancies,  
         Hematology support, Pediatric Hematology  
    Division of Hematology Oncology Toxicology (DHOT) 301-796-2340 
         Nonclinical Review Division for Hematology/Oncology Product 

Office of New Drug Quality Assessment (ONDQA) 
  
 301-796-1900
Office of Biotechnology Products (OBP)      301-796-2390