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REMS
CDER Issues New MAPP For REMS Assessment Reviews
The US Food and Drug Administration (“FDA”) recently issued a Manual of Policies and Procedures (“MAPP”) describing how the Center…
GAO Report on Access to REMS Drugs Shows Mixed Views on Path Forward
The GAO recently published a report, entitled Generic Drug Development – Stakeholders’ Views of Risk Evaluation and Mitigation…
FDA Finalizes Revised Guidance on REMS Revisions and Modifications
The US Food and Drug Administration (“FDA”) finalized a revised guidance on making modifications to risk evaluation and mitigation…
REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is…
Recently the FDA issued final guidance on FDA’s application of the statutory factors in determining when a risk evaluation and…
JAMA Article Outlines REMS Failure, Suggests Reforms
In a recent JAMA article, “Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release…
FDA Releases Two Draft Guidances on REMS Programs
On January 24, 2019, the United States Food and Drug Administration (FDA) released two draft guidances focused on improving the…
FDA Releases Two Draft Guidance Documents on REMS
In May 2018, the United States Food and Drug Administration (FDA) issued two draft guidance documents focused on developing a…
FDA Publishes List of Drug Companies Allegedly Blocking Access to Drug…
The United States Food and Drug Administration (FDA) has recently publicized a list of forty-one branded drug companies that have…
FDA REMS Blueprint on Opioids Finalized
On January 30, 2018, the United States Food and Drug Administration (FDA) finalized the “Opioid Analgesic REMS Education…
FDA Offers Draft Guidance on E-Submissions of REMS Documents
The FDA recently released draft guidance describing how FDA plans to implement the requirements for the electronic submission of…