FDA

Published on:
Monday, May 8, 2017

This report contains explanations and examples of the types of data that ACCME has collected about ER/LA Opioid REMS continuing education provided by ACCME and SMS-accredited providers.

Published on:
Thursday, April 20, 2017

The ACCME submitted a letter to Sen. McCaskill, Ranking Member, Committee on Homeland Security and Governmental Affairs, to address her investigation of the opioid epidemic. In the letter, Graham McMahon, MD, MMSc, President and...

Published on:
Friday, July 22, 2016

The provider participates in a national system framework for quality improvement in clinical trials research.  This program supports the quality of clinical trials research, including human subjects’...

Published on:
Tuesday, April 26, 2016

The ACCME submitted these comments for the FDA public advisory committee meeting on the Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS, May 3–4, 2016. In the comments, Graham McMahon, MD, MMSc, President and CEO,...

Published on:
Tuesday, December 16, 2014

The ACCME, the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), issued this joint response to the Food and Drug Administration (FDA) report Standardizing and Evaluating...

Published on:
Tuesday, December 16, 2014

The ACCME sent this letter in response to the Food and Drug Administration (FDA) report Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS). The letter offers observations and suggestions for...

Published on:
Friday, November 22, 2013

Accredited CME providers that are interested in conducting the long-term evaluations might provide service in support of the ER/LA Opioid Analgesics REMS in the following ways:

  1. Providers can...
Published on:
Friday, November 22, 2013

REMS-related accredited CE activities meet some but not all of the requirements established by the FDA in its definition of a REMS-compliant...

Published on:
Friday, November 22, 2013

The FDA has provided the following description of the REMS Long-Term Evaluations in its ER/LA Opioid Analgesics REMS Supporting Document:

“A subset of CE providers capable of conducting evaluations of long-term performance...

Published on:
Friday, November 22, 2013

According to the FDA, the goal of REMS is to ensure that the benefits of a drug or biological product outweigh its risks. The FDA may require a...

Published on:
Friday, November 22, 2013

The CE community addresses prescription drug abuse in many ways. One way is by developing and presenting education that is explicitly part of the RPC-funded ER/LA Opioid Analgesics REMS that meets all the specific REMS requirements...

Published on:
Friday, November 22, 2013
  • CME in Support of REMS: This ACCME Web Page provides updates and resources for accredited CME providers that...
Published on:
Friday, November 22, 2013

The companies that have come together as a consortium of opioid manufacturers, the REMS Program Companies (RPC), are the entities responsible to the FDA.

...
Published on:
Friday, November 22, 2013

The FDA has required long-term evaluations of the ER/LA prescribers who complete REMS-compliant CE activities. Specifically, the FDA is requiring the evaluation of knowledge retention and practice change in ER/LA opioid prescribers...

Published on:
Friday, November 22, 2013

The RPC has hired inVentiv Health, Ltd. to manage the commercial support. So, in this complicated case, for simplicity, the accreditor is allowing providers to specify the “RPC/inVentiv Health, Ltd.” as the commercial supporter....

Published on:
Friday, November 22, 2013

For the ER/LA Opioid Analgesics REMS, the FDA writes that: Training will be...

Published on:
Friday, November 22, 2013

The REMS Program Companies (RPC) are responsible to the FDA for fulfilling the requirements for long-term evaluations.  The RPC will provide funding to...

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, August 6, 2013

Murray Kopelow, MD, ACCME President and CEO, gave this presentation, "Accredited Prescriber Education in Support of REMS," at the FDA Standardizing and Evaluating REMS Public Meeting, held July 25­­-26, 2013.

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-...

Last Revised:
January 23, 2012
Published on:
Monday, January 23, 2012

This presentation slide set was delivered by representatives from the ACCME, the Food and Drug Administration, and AstraZeneca during the session entitled "Risk Evaluation and Mitigation Strategies:  Developing REMS (CE) in...

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