Log in for full access to this activity, if you are registered.

Registration Options

Activity Dates: 05/04/2011 - 05/04/2014

This course is closed. Please look for other available products in CPNP University.

Target Audience

If you are a pharmacist, nurse practitioner or other healthcare professional involved in the comprehensive medication management of psychiatric and/or neurological patients, we invite you to participate in this online course.

Session Summary

The Federal Food Drug and Cosmetic act states that approval of a drug requires “substantial evidence” from “adequate and well-controlled investigations”. The Code of Federal Regulations (CFR) codifies the FD&C Act and provides more details regarding what are considered to be adequate and well-controlled investigations. Guidance documents were developed to provide more detailed information, many times specific to the indications being studied, on various topics including clinical trial designs. Unlike the CFR, guidance documents represent the FDA’s current thinking on a given topic and do not establish legally enforceable responsibilities.

At the time a new drug is approved, there may be little clinical trial data available in the public domain, e.g., published in scientific journals or elsewhere. This presentation will discuss what clinical trial data may be found on the FDA website and the limitations of these data. Finally, clinical trials data will be discussed for a recent regulatory action to illustrate issues that arise during the review process.

Course Requirements

You will proceed through the following steps to satisfactorily complete this course:

  • Review the full content of the activity and reflect upon its teachings.
  • Complete the post-test at the end of the activity no later than the closing activity date. (login first)
  • Complete the evaluation at the end of the activity. (login first)
  • Receive a passing grade (60%).
  • Provide the necessary details in your profile to ensure correct reporting by CPNP to CPE Monitor. (login first)

This course is provided online at cpnp.org and consists of the speaker audio and slides. A PDF file of the slides is also provided and access is available to participants indefinitely although ACPE credit is available only through the course expiration date.

Participants in this course must complete an examination and achieve a score of 60% or greater. Successful completion of the course also requires the completion of a course evaluation. ACPE statements of credit can be retrieved by participants online at cpnp.org immediately upon successful completion of the course.

Faculty Information and Disclosures

Learning Objectives

  1. Identify the criteria by which drugs must demonstrate efficacy as defined in the Code of Federal Regulations (CFR).
  2. Differentiate between regulations as defined in the CFR and Guidance documents.
  3. Identify the strengths and limitations of the types of clinical data available on the FDA website. 
  4. Understand the drug evaluation process via an example of a recent FDA regulatory decision.

Continuing Education Credit and Disclosures

Activity Dates: 05/04/2011 - 05/04/2014
ACPE Contact Hours: 1.0
ACPE Number: 0284-9999-11-020-H04-P (Knowledge)
Nursing Credit Reminder: Note that ACPE credit is accepted for certification renewal.

ACPEThe College of Psychiatric and Neurologic Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This self-study course provides 1.0 contact hours (0.10 CEUs) of knowledge-based continuing education credit from CPNP approved programming. The ACPE universal program number assigned to this course is 0284-0999-11-004-H04-P (1.0 contact hours).

ACPE approved contact hours are accepted for ANCC Certification Renewal (see pages 5 and 6): At least 50% (37.5 hours) of your 75 continuing education hours must be formally approved continuing education hours. Formally approved continuing education hours meet one or more of the criteria listed below:

  1. Continuing nursing education (CNE) approved for nursing contact hours by an accredited provider or approver of nursing continuing education
  2. Continuing medical education (CME) approved for CME hours
  3. Sponsored by organizations, agencies, or educational institutions accredited or approved by the American Nurses Credentialing Center (ANCC) or the Accreditation Council for Continuing Medical Education (ACCME) or the Accreditation Council for Pharmacy Education (ACPE) or the Commission on Dietetic Registration

Grant Support

This programming was supported in part by grants from Bristol-Myers Squibb, Cyberonics, Merk and Sunovion.

Annual Meeting Grant Supporter