The FDA: Inside the Black Box-A Discussion of Regulations and Recent Decisions

The FDA:
Inside the Black Box-A Discussion of Regulations and Recent Decisions

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

Registration Options

The FDA: Inside the Black Box-A Discussion of Regulations and Recent Decisions ~ Member Rate - $25.00

The FDA: Inside the Black Box-A Discussion of Regulations and Recent Decisions - $30.00

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.

Registrant Resources

Sorry, but you are not an authorized user. Please register for the course at the top of this page.

Faculty Information

Cara Alfaro, PharmD

View biographical information and disclosures

Cara Alfaro, PharmD
Clinical Analyst
Division of Psychiatry Products-Center for Drug Evaluation and Research
Food and Drug Administration
Silver Spring, MD

Cara Alfaro, Pharm.D., is a Clinical Analyst with the Division of Psychiatry Products at the Center for Drug Evaluation and Research at the Food and Drug Administration. Dr. Alfaro received her B.S. degree in pharmacy at Purdue University in 1989 and her Pharm.D. degree at the Ohio State University in 1991. She then completed a one-year specialty residency and two-year fellowship in psychiatric pharmacy at the University of Texas Health Science Center at San Antonio. After completing her fellowship, Dr. Alfaro continued at the University of Texas as Clinical Assistant Professor where her primary research interests included drug metabolism and drug-drug interactions of psychotropics with emphasis on the cytochrome P450 system. She was a recipient of the NIMH New Investigator Award in 1996 for research in this area.

In 1998, Dr. Alfaro joined the National Institutes of Health as a Clinical Pharmacy Specialist for the National Institute of Mental Health. At the NIH she worked closely with researchers evaluating novel treatments for psychiatric and neurologic disorders including Alzheimer’s disease, Bipolar Disorder, Major Depression, and Schizophrenia (adult and childhood-onset). Dr. Alfaro was also a member of the NIMH IRB.

In 2002, Dr. Alfaro joined the Food and Drug Administration and is among a handful of non-physician clinical analysts within CDER and the only non-physician clinical analyst within the Division of Psychiatry Products. She is responsible for the clinical review of safety and efficacy of investigational drug products for psychiatric indications. Dr. Alfaro is responsible for approximately 30 INDs and has reviewed 10 supplemental NDAs and New Molecular Entities (NMEs). She has also been a speaker on the FDA symposium at several annual NCDEU meetings.

Learning Objectives

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

Continuing Education Credit

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 and ACCME credit is accepted for certification renewal.

View complete continuing education credit details

ACPE The 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:

Continuing nursing education (CNE) approved for nursing contact hours by an accredited provider or approver of nursing continuing education
Continuing medical education (CME) approved for CME hours
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

Course Requirements

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.

View System Requirements to Access All Session Resources

Minimum:

Internet Explorer 6+, Firefox 2+ or Safari 3+
1024x768 resolution or greater
Adobe Flash Player 8+
512MB RAM
Any Operating System capable of the above requirements

Recommended:

Internet Explorer 7+, Firefox 3+ or Safari 3+
1280x768 resolution or greater
Adobe Flash Player 10+
Windows XP/2000/Vista and Mac OS 10.4 or better
512MB of RAM for Windows XP or Mac OS
1GB of RAM for Windows Vista

Target Audience

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

Grant Support

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