viernes, 13 de octubre de 2017

Summary of REMS@FDA website updates for August and September

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. Opsumit REMS modified (on August 25, 2017) to: 
  • Clarify the reproductive status of females who had tubal sterilization as Female of Reproductive Potential (FRP).
  • Remove non-REMS information and consent language from the patient enrollment forms. 
  • Clarify that re-enrollment of patients is not required by certified prescribers within the same practice.
  • Make editorial changes and revisions throughout the Opsumit REMS to improve implementation of the REMS.
  • Make editorial changes to the REMS website consistent with the redlined comments from the Agency's 8/1/17 comments. 
2. Kymriah REMS approved August 30, 2017.

3.  Tracleer REMS modified (on September 5, 2017) to add an additional NDA number (209279) and remove the reference to the Dear Healthcare Provider Letter, as well as changes to the REMS website and materials that update the indication to include pediatric patients.

4. Transmucosal Immediate-Release Fentanyl (TIRF) Shared System REMS modified (on September 7, 2017) to make changes to the REMS document, and appended materials consistent with the safety label changes approved on December 16, 2016, as well as additional minor modifications.

5. Testosterone 1% REMS (ANDA 091073) approved September 18, 2017.

6. Suboxone/Subutex REMS  modified REMS materials (on September 19,2017) to be consistent with the safety labeling changes approved on December 16, 2017.

7. Emtricitabine/tenofovir disoproxil fumarate REMS revised (on September 21, 2017) to correct a typographical error (s).

8. Letairis REMS modified (on September 27, 2017) to add an online enrollment option for patient and prescriber enrollment. 

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