REMS Turns Two Years Old: "Terrible Two's" or REMS 2.0?

Presentation hosted by ParagonRx: Thursday, November 5, 2009 @ 7:45am

Gary Slatko, M.D., MBA, Chief Medical Officer, ParagonRx

In September 2007, Congress enacted the FDA Amendment Act granting FDA sweeping new authorities, including the ability to require Risk Mitigation and Evaluation Strategies (REMS) of any product with risks that cannot be adequately addressed by labeling alone. Since then, FDA has been extending its REMS authority beyond safety risks, also addressing a drug's relative efficacy as well as trying to mitigate off-label uses, the normal purview of prescribing physicians. FDA has, during the past eight years of risk management and REMS programs, moved beyond reacting to drug safety crises with new regulations to trying to prevent crises before they happen. For better or worse, that means the FDA is now working in areas that once were handled strictly by pharmaceutical companies and addressing prescription issues that were once the special preserve of doctors.

Presentation Slide Set (click to view):

Presented at the 4th Annual Post-Approval Drug Safety Strategies - Best Practices to Assess and Mitigate Risks throughout the Product's Life Cycle.


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