lunes, 18 de abril de 2016

REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS) website updated

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. Soliris REMS modified (April 13, 2016) to add language regarding storage instructions in the REMS appended material, Dosing and Administration Guide, as reflected in the January 11, 2016 labeling and updating the sponsor’s address on the REMS document.
  2. Addyi REMS modified (April 8, 2016) to add the prescriber's practice setting to the Prescriber Enrollment Form and the addition of the authorized representative's professional title to Outpatient Pharmacy Enrollment Forms.
  3. Lemtrada REMS modified (April 5, 2016) to make administrative and typographic changes to two Lemtrada REMS materials (the REMS Letter for Healthcare Providers and the Lemtrada REMS Infusion Checklist), and administrative and typographic changes along with an update to the Lemtrada REMS website.
  4. Afrezza REMS revised (April 1, 2016) to change the applications holder’s name or address.
  5. Alosetron REMS modified (March 24, 2016) to change the website in the Prescriber Information section, to include the addition of a text box on the Prescriber Online Training Form.
  6. Vibativ REMS modified (March 23, 2016) to change the communication plan to add one more distribution of the Dear Healthcare Provider (DHCP) Letter to healthcare providers. In addition, the requirement for professional societies to distribute the DHCP letter has been removed from the communication plan.
  7. Truvada REMS modified (March 10, 2016) to update updating the Training Guide for Healthcare Providers; Healthcare Provider Education Slide Deck; and Important Safety Information for Healthcare Providers  with a coadministration warning for medicines that contain tenofovir alafenamide. Additionally, an update to the Important Safety Information About TRUVADA to Reduce the Risk of Getting Human Immunodeficiency Virus–1 (HIV-1) Infection  (booklet)to include addition of medicines which contain tenofovir disoproxil fumarate or tenofovir alafenamide (GENVOYA® or ODEFSEY®) and to add DUTREBIS® to list of medicines containing lamivudine is included in this modification.
  8. Opsumit REMS modified (Feburary 22, 2016) to approve a new Opsumit Patient Enrollment and Consent Form for VA Use Only.

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