blueprint

Published on:
Friday, November 22, 2013

The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require manufacturers of drugs and biological products to put in place special programs if the FDA determines that safety measures are needed...

Published on:
Tuesday, October 29, 2013

Yes. ACCME will report this data, in aggregate, to the stakeholder community. 

Published on:
Tuesday, October 29, 2013

As a service to the CME community and to the FDA, the ACCME has agreed to contribute to fulfilling the data collection and auditing requirements for the ER/LA Opioid Analgesics REMS. The ACCME has modified its...

Published on:
Tuesday, October 29, 2013

Yes. You can download a report of the REMS-specific data associated with your REMS activities, by clicking on the Activities tab, and then clicking on Download REMS Activities from the left-hand navigation menu. Note that this...

Published on:
Tuesday, October 29, 2013

The ACCME has modified PARS to accept the data mandated by the FDA, including how many REMS CME activity participants prescribed ER/LA opioids within the last year, and a breakdown of these individuals by profession. Accredited CME...

Published on:
Tuesday, October 29, 2013

No. The ACCME does not require accredited providers to offer REMS-compliant or REMS-related CE activities. There are no new or special accreditation requirements for accredited providers within the ACCME system...

Published on:
Tuesday, October 29, 2013

Providers accredited by the ACCME or an ACCME Recognized Accreditor can participate in the data collection process by entering REMS data in the REMS section of the web-based interface in PARS for each REMS activity they provide....

Published on:
Tuesday, October 29, 2013

In order to provide an equitable process for all accredited CME providers within the ACCME system, the ACCME is assessing a per activity fee from accredited CME providers that receive commercial support from the REMS Program...

Published on:
Tuesday, October 29, 2013

The FDA has mandated that the REMS Program Companies (RPC) report to the FDA on the progress of implementing the ER/LA Opioid Analgesic REMS and that there be an independent audit of REMS-compliant accredited CE activities to...

Published on:
Tuesday, October 29, 2013

At the bottom of the Add an Activity screen, you will see a section called Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS). Follow the instructions to enter data about REMS-compliant and REMS-...

Published on:
Thursday, October 25, 2012

No. An accredited CME provider cannot use content developed by an ACCME-defined commercial interest in CME activities because that would be noncompliant with Standard for Commercial Support 1: Independence.

It is acceptable...

Published on:
Thursday, October 25, 2012

Yes. There is no ACCME prohibition against including product-specific content in accredited CME. Accredited providers can develop and distribute product-specific content for activities based on the FDA blueprint for the Extended-...

Published on:
Thursday, October 25, 2012

No. The ACCME information applies only to the ER/LA Opioid Analgesics REMS. The ACCME appreciates that the FDA recognizes the value of accredited  education and believes that accredited CME should be considered as a strategic asset...

Since 2009, the ACCME has supported the role of accredited CME as a strategic asset to US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS), provided the proper...

FDA REMS Meetings, Fact Sheet for CME Providers

The ACCME has participated in two meetings with the Food and Drug Administration (FDA) about Risk Evaluation and Mitigation Strategies (REMS). We...

Last Revised:
August 27, 2012

In the Extended-Release and Long-Acting Opioid Analgesics REMS, one of the elements to assure safe use is an education program for prescribers about the risks of opioid medications as well as safe prescribing and safe use practices...

Last Revised:
August 27, 2012

Yes. Accredited CME providers can base their activities on the FDA blueprint and be in compliance with the...

On July 9, the US Food and Drug Administration (FDA) released its Risk Evaluation and Mitigation Strategy or REMS for extended-release and long-acting (ER/LA) opioid analgesics.

The centerpiece of the ER/LA Opioid Analgesic...

Here are additional resources to support accredited CME providers that choose to design education to address the goals of the FDA Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and...