Risk Evaluation and Mitigation Strategies

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REMS for OPOIDS

Friday, 16 April 2010 09:48 administrator
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This will forward you to a, Ready for REMS, an educational initiative developed by leading pain management experts in collaboration with Cephalon to raise awareness and prepare healthcare providers for the FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) for opioids.

 

FDA Guidance for Industry

Click here to read the Guidance (from the FDA website)

 

REMS Implications, Opportunities and Learnings for All Professionals

Purpose Statement: This medical education program will not only educate medical professionals on the logistics of the REMS requirement, but will also discuss how this program might present various challenges and opportunities in the healthcare settings for all stakeholders.

Target Audience: This continuing medical education program is designed for all healthcare professionals.

Disclaimer: The information provided at this CE activity is not meant to substitute for the independent medical judgement of a healtcare provider relative to diagnostic and treatment options of a specific patient's medical condition.

To learn more and/or participate in this CME activity, click here 

 

Approved REMS (fda.gov)

This is a link to the FDA's website showing approved Risk Evaluation and Mitigation Strategy Plans. Click Here

 

FDAAA empowers FDA to have greater control over drug safety

Congress approved the FDA Amendments Act of 2007 (FDAAA) in September after a lengthy debate that resulted in compromises on many issues. The resulting law contains numerous provisions designed to better inform the public about drug safety and provides new tools for FDA to reduce risks and unsafe drug use. Click here to read more

 

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