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:
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...

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-...

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...

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...

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...