viernes, 7 de julio de 2017

A REMS@FDA website update: June 2017 summary

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The FDA's REMS website, REMS@FDA, has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
  1. ThalomidRevlimid, and Pomalyst REMS modified (on June 27, 2017) to:
    1. Remove reference to the previous REMS program names.
    2. Remove the CD-ROM/desktop software as a method to enroll patients into the REMS.
    3. Add clarifying language regarding contraception use requirements for contraception use by patients enrolled in the REMS.
    4. Update the name of the Veterans Health Administration in the REMS document and the materials.
    5. Add a tear-off quick reference guide for prescribers in the REMS at a Glance appended material.
    6. Add REMS contraception information for patients to be used by non-prescribing healthcare providers.
    7. Add an updated brochure regarding emergency contraception.
  2. Isotretinoin iPLEDGE shared system REMS modified (on June 17, 2017) to provide for implementation of a REMS Pharmacy Network and use of an electronic verification system for iPLEDGE Program certified pharmacies to request and receive a Risk Management Authorization (RMA) directly through the prescription claim adjudication process workflow at the point of dispensing an isotretinoin prescription. It also provides for the changes made to the REMS educational materials to streamline and improve clarity.
  3. Addyi REMS modified (on June 16, 2017) to emphasize that pharmacists must counsel patients with each prescription in the Addyi REMS Prescriber and Pharmacy Training Program and to update the presentation of the Applicant's company name and trademark symbol on all REMS materials.
  4. Emtricitabine/tenofovir disoproxil fumarate shared system REMS approved (on June 8, 2017).
  5. Siliq REMS modified (on June 8, 2017) to make editorial changes to the REMS document and Patient-Prescriber Agreement Form; and corrections and clarifications for the REMS website content.

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