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REMS
FDA Public Meeting on Training Health Care Providers on Pain Management and…
In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that…
FDA Public Workshop on Opioid Training
The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with…
FDA Issues Guidance on REMS
With the passage of the long-awaited 21st Century Cures legislation, we saw Senator Mike Lee (R-UT) vote “no” because the bill did…
FDA ER-LA REMS Day 2 of the Drug Safety and Risk Management Advisory…
Day Two of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and…
Endo New York Settlement Announcement
New York Attorney General Eric T. Schneiderman announced an agreement with Endo Health Solutions, Inc. and Endo…
New Hampshire Legislation Targets Boards that Govern Opioid Prescribers
This year the presidential primaries in New Hampshire are bringing to national attention the crisis of Opioid addiction.…
Update on Risk Evaluation and Mitigation Strategies
For many years, we have written about the authority granted to the FDA from the 1997 Food and Drug Administration Amendments Act…
FDA REMS Open Public Meeting Explored Need for Flexibility in REMS Programs
The Food and Drug Administration (FDA) held a meeting on July 25th and 26th, 2013, to discuss Risk Evaluation and Mitigation…
FDA REMS: FDA Hosting a Two Day Meeting on Issues and Challenges with REMS…
Over the past year, we have written several times about the Food and Drug Administration's (FDA) goals to standardize Risk…
FDA MedWatch Safety and Adverse Event Reporting Program Expands Patient…
Earlier this month, the Food and Drug Administration (FDA) celebrated the
20th anniversary
of its
MedWatch program, which…