REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
- Extended-Release Long-Acting (ER/LA) opioid analgesics shared system REMS modified (on August 13, 2015) to change the ER/LA Opioid Analgesics REMS Blueprint to include the following information:
- Incorporation of information regarding use of OXYCONTIN in the pediatric population
- Addition of information to the titration recommendations for adult patients.
- Modify the timeframes in which REMS letters will be sent to certain healthcare providers and professional societies;
- Remove the requirement that the REMS letter be provided to Medwatch prior to the letter being issued;
- Modify the timeframe in which the REMS Factsheet will be displayed at certain scientific meetings.