CDER New February 8, 2019

February 7, 2019

• Reference Listed Drug (RLD) Access Inquiries (Updated)
• Tenth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017
• Manual of Policies and Procedures (MAPP) 6701.3 Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures (PDF - 353 KB)