Best Practices for Communication between FDA and Applicants during the NDA Review Cycle: A PhRMA White Paper
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David M. Cotchetto, PhD US Regulatory Affairs. GlaxoSmithKline, Research Triangle Park, North Carolina Jennifer 1. Stotka, MD US Regulatory Affairs. Eli Lilly and Company, Indianapolis. Indiana Diane Zezza, PhD Schering-Plough Corporation, Kenilworth. New jersey Thomas H. Hassoll, MS, RPh Global Pharmaceutical Regulatory Affairs. Abbott. Rockville. Maryland Gregory Brophy, PhD US Regulatory Affairs,
Eli Lilly and Company, Indianapolis. Indiana Donna Peterson Amgen. Rockville, Maryland
Key Words GRMPs; Best practices; Communication CorrespondenceAddress David M. Cocchetto. PhD. GlaxoSmithKline. 5 Moore Drive, Research Triangle Park, N C 27709 (e-mail: david.m.cocchetto@ GSK.com).
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Best Practices for Communication Between FDA and Applicants During the NDA Review Cycle: A PhRMA White Paper The p a s of development, manufacturing, rcgistmtion, distribution, and postmarlcm'ng suppu?iofand bidogic products indudes the need for dcm; active, and ongoingcommunication between the sponsor/applicant and the Food and Drug Administrution (FDA). !hch communication oc(ws in Wntten and spoken f a , invobiqg multiple media (inchding letters, secure e-mail, fax, face-to-face meetings, and tdemnfmnces). Personnel in PhRMA member companies and FDA recognize the importance and ddenges of communication. FDA's attention to a number of key principles of communication is illustrated in the guidance document Good Review Management Principles and Practices for PDUFA Products. In
INTRODUCTION FDA's guidance document, Good Review Management Principles and Practices for PDUFA Products, includes the following statement: "Applicants are encouraged to work with RPMs (regulatory project managers), particularly at the time of application submission, to create a clear communication strategy" (1). In view of this call by FDA for creation of a clear communication strategy to facilitate the review process, the Best Practices Working Group of PhRMA (the Pharmaceutical Research and Manufacturers of America) has drafted several specific statements of expectations for communication between companies and FDA. These expectations and points for consideration should facilitate a shared understanding that is consistent across reviewing divisions between FDA and multiple companies with respect to the main aspects of a clear communication strategy. The Best Practices Working Group wants to foster additional discussion of this information among representatives of PhRMA companies and as part of a di-
this white paw members of P W s Best Pmctices Working Group have summarized key infaation on communication j h the guidance doannent,plopNxped expectations for communications to facilitate a shared understanding betwm FDA and applicant about a communicationstrategy during review of a New Drug Application (NDA) or Bidogics License Application @LA), and dmfied some basicprinciplesfor companies to adopt to helpfoster consttuctive, professional, and &cient communication with FDA on M p t i o n Drug User Fee Act (PDUFA) promcctS. Dialogue with FDA and other stakeholder
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