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@KeeyanGhoreshi
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update of the documentation links to actually link to the REMS document for iPledge and TIRF.

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I think we should add additional materials to the forms according to the list below:

Turalio

Patient
Documentation Requirements - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_REMS_Document.pdf
Patient Guide - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Patient_Guide.pdf
Medication Guide - https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Turalio_Med&inline=true
Patient Enrollment Form - Questionnaire
Patient Status Form - Questionnaire

Prescriber
Documentation Requirements - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_REMS_Document.pdf
Prescribing Information - https://daiichisankyo.us/prescribing-information-portlet/getPIContent?productName=Turalio&inline=true
Program Overview - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Program_Overview.pdf
Prescriber Training - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Turalio_2020_12_16_Prescriber_Training.pdf
Prescriber Enrollment - Questionnaire
Prescriber Knowledge Assessment - Questionnaire

TIRF

Patient
Documentation Requirements - https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_REMS_Document.pdf
Patient Counseling Guide - https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Patient_Counseling_Guide.pdf
Patient FAQ - https://tirfstorageproduction.blob.core.windows.net/tirf-public/tirf-patientfaq-frequently-asked-questions.pdf
Patient Enrollment Form - Questionnaire

Prescriber
Documentation Requirements - https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_REMS_Document.pdf
Prescriber Education - https://www.accessdata.fda.gov/drugsatfda_docs/rems/TIRF_2022_08_17_Prescriber_Education.pdf
Prescriber FAQ - https://tirfstorageproduction.blob.core.windows.net/tirf-public/tirf-prfaq-frequently-asked-questions.pdf
Prescriber Enrollment - Questionnaire
Prescriber Knowledge Assessment - Questionnaire

Isotretinoin iPLEDGE

Patient
Documentation Requirements - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_REMS_Document.pdf
Fact Sheet - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Fact_Sheet.pdf
Guide for Patients who can get Pregnant - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Guide_for_Patients_Who_Can_Get_pregnant.pdf
Contraceptive Counseling Guide - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Contraception_Counseling_Guide.pdf
Patient Enrollment Form - Questionnaire

Prescriber
Documentation Requirements - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_REMS_Document.pdf
Prescriber Guide - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Prescriber_Guide.pdf
Comprehension Questions - https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2021_10_8_Comprehension_Questions.pdf
Prescriber Enrollment - Questionnaire

@smalho01 smalho01 merged commit 929742e into master Sep 20, 2022
@smalho01 smalho01 deleted the documentation-links branch November 2, 2022 18:29
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4 participants