viernes, 2 de marzo de 2018

Summary of REMS@FDA website updates for January & February, 2018

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. Siliq (brodalumab) REMS modified January 26, 2018 to reflect the following changes:
  • Enable pharmacy staff members to associate with a certified pharmacy
  • Allow for patient access to the list of certified prescribers via the REMS website
  • Clarify product quantity unit of measurement
  • Provide a link on the REMS website to Spanish-language versions of the Patient Prescriber Agreement (PPA) Form and Patient Wallet Card.

2. testosterone REMS (ANDA 209533) approved January 30, 2018.

3.  Zydelig (idelalisib) REMS modified graphics and REMS logo color scheme on February 6, 2018.

4. Sublocade (buprenorphine extended-release) REMS revised February 9, 2018 to update 
    mailing address.

5.  Apadaz (benzhydrocodone and acetaminophen) REMS  approved February 23, 2018.

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