REMS
FDA REMS Modification Advances Opioid Mail-Back Disposal Option
The FDA will require participating companies to begin providing prepaid drug mail-back envelopes upon request ...
NOVEMBER 8, 2024
FDA Mulls New Mail-Back Approach for Unused Opioids
The FDA is seeking public comment on potential changes to the existing opioid REMS to include a postage–paid, ...
MAY 12, 2022
FDA, Duke-Margolis Workshop Focused on Key Competencies for Opioid Prescriber Education
The FDA will co-host a two-day virtual public workshop on April 4-5, 2022, on identifying gaps in the content of ...
MARCH 16, 2022
FDA Launches New Public Dashboard for REMS Data
The FDA launched a new public dashboard for medications that are required to comply with the agency’s Risk ...
JANUARY 26, 2022
FDA Announces Workshop on Possible Mandatory Opioid Prescriber Education
The FDA will hold a two-day virtual public workshop on potentially requiring prescribers of opioids to complete ...
SEPTEMBER 14, 2021
TIRF REMS Changes Leads to Issues With Prescriber Recertification
Changes to the Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products has ...
MAY 3, 2021
FDA Bolsters Opioid Tolerance Provisions in REMS Program for Transmucosal Immediate-Release Fentanyl Products
The FDA announced plans to strengthen its Risk Evaluation and Mitigation Strategies program for transmucosal ...
JANUARY 14, 2021
FDA Updates REMS Policy on Access To Opioids During COVID-19 Pandemic
The FDA announced a temporary policy for certain Risk Evaluation and Mitigation Strategy requirements for the ...
MAY 6, 2020
Study Questions Role of FDA, Manufacturers in Off-Label Prescribing of Transmucosal IR Fentanyl Products
The FDA and drug manufacturers failed to act when Risk Evaluation and Mitigation Strategy (REMS)–mandated ...
JULY 22, 2019
FDA Advisory Committees See ‘Red Flags’ in TIRF REMS
A FDA advisory committee raised concerns with the TIRF REMS program after reviewing data during a recent public ...
AUGUST 7, 2018
FDA Updates Provider Blueprint for Treating Pain Patients
The FDA has posted its revised and updated blueprint for health care providers who treat patients with pain.
JANUARY 30, 2018
FDA Report About Discussing REMS With Patients Available
A new FDA report outlines best practices for counseling when discussing drugs with REMS.
OCTOBER 31, 2017