CRED+ Optimising Interaction with Regulators

References for meetings / interactions in the EU and US

US FDA - SOPPs and MaPPs • Manual of Policies & Procedures (CDER) https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPolicie sProcedures/default.htm • SOPP 8101.1: Scheduling and Conduct of Regulatory Review Meetings with Sponsors and Applicants Effective Date October 01, 2017 • SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA) Effective Date: December 01, 2013 • MAPP 6025.6 - Good Review Practice: Management of Breakthrough Therapy- Designated Drugs and Biologics Effective Date: 7/29/14 • MaPP 4151.1Rev1 - Scientific/Regulatory Dispute Resolution for Individuals Within a Management Chain Effective date: 9/16/10 • MaPP 4151.2Rev1 - Resolution of Differing Professional Opinions: Review by Ad Hoc Panel and CDER Director Effective date: 9/16/10 • MaPP 4150.1 - Role and Procedures of the CDER Ombudsman Effective Date: 10/10/02

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