Summary of REMS@FDA Website Updates for March and April, 2020

Summary of REMS@FDA Website Updates for March and April, 2020

1. Tegsedi (inotersen) REMS modified May 11, 2020 to make: Changes to the Prescriber Enrollment Form that include the addition of name and contact information fields related to prescriber delegates. Updates to the Patient Status Form including a section that indicates the form may be submitted by a prescriber delegate and the ability of the prescriber to choose from a range of platelet counts to further clarify the level of thrombocytopenia that led to discontinuation. Updates to the Prescriber Knowledge Assessment to revise the answer to one of the questions. Also revised to make editorial changes. 2. Pomalyst (pomalidomide ) REMS modified May 14, 2020 to remove indication statements from REMS materials; modified the REMS document to the new format to align with the recommendations in the October 2017 Draft Guidance: Format and Content of a REMS Document for Industry; and remove prescription forms from the REMS. 3. Natpara (parathyroid hormone) REMS modified June 05, 2020 to change the timetable for submission of assessments from annually to every two years beginning with the REMS assessment for year six (72-month) and modified the REMS document to the new format to align with the recommendations in the October 2017 Draft Guidance: Format and Content of a REMS Document. 4. Sublocade (buprenorphine extended-release) REMS modified June 15, 2020 to change the REMS Document to update audit plans for healthcare settings and pharmacies. 5. Fintepla (fenfluramine) REMS added June 25, 2020.