CDER Teleconference: An Introduction to the Improved FDA Prescription Drug Labeling

CDER Teleconference:
“An Introduction to the Improved FDA Prescription Drug Labeling”

Tuesday, November 7, 2006
12:30 p.m. – 2:00 p.m. Eastern time

Handouts and an audio download of this teleconference are available on the ISMP website. To receive an audio CD and handouts by mail, please email dpapubs@fda.hhs.gov.

Overview

Prescribing information – commonly called the “package insert” – is getting a new look. FDA has revised its rules for the content and format of prescribing information for prescription drug and biological products.

The changes to drug prescribing information are intended to improve patient safety by making it easier for health-care professionals to access, read, and use prescribing information, and increase the extent to which health-care professionals rely on it.

This teleconference will discuss the changes and the role they play in patient safety.

Topics include:

  • an overview of prescription drug labeling and related FDA requirements
  • the history of the drug labeling initiative
  • the implementation schedule for the revised prescription drug labeling
  • the major content and format changes to prescription drug labeling and the rationale for the changes
  • related FDA electronic labeling initiatives

Moderator: To be announced later.

Introduction by Michael Cohen, R.Ph., M.S., Sc.D, Institute for Safe Medication Practices

Speakers:
Rachel Behrman, M.D., M.P.H., U.S. Food and Drug Administration
Renu Chhabra, Pharm.D., LCDR, USPHS, U.S. Food and Drug Administration
Janelle Derbis, Pharm.D., LCDR, USPHS, U.S. Food and Drug Administration
Brenda Evelyn, SBB (ASCP), U.S. Food and Drug Administration
Mary Kremzner, Pharm.D., CDR, USPHS, U.S. Food and Drug Administration
Theresa Toigo, R.Ph., M.B.A., CAPT, USPHS, U.S. Food and Drug Administration

Fees:
There is no charge for participation in this teleconference.

Accreditation Information:
No continuing education credit will be given for this teleconference.


Need A ReNu Attorney?

First Name Last Name Email Address State
Was Your Health Negatively Affected?

Please Describe the Injury

Your Friend's Email Address

Your Email Address

Type a Message (optional)


 

Close (x)

Looking for an Attorney?


Please type your question:

Close (x)

logo Find Legal Help for Your ReNu Case - Submit Your Information Below

Do you need legal assistance with your ReNu case?
LegalView may be able to help.


Submit your information below for a free, no-cost evaluation.

We'll submit your information to one of our partner firms.
LegalView's partners represent clients throughout the United States, for a very wide range of legal issues. Submit your information now, to see if one of LegalView's partners can help!

* Indicates Required Fields

First name *
Last name *
Email Address *
Phone Number *
()  -

State *
Legal Issue * Unsafe Drugs: ReNu Change
Was There an Injury?
Please Describe The Injury

DISCLAIMER and STATEMENT OF NON-CONFIDENTIALITY

By submitting this form, you agree that completing the above is not intended to create an attorney-client relationship.

Disclosure

Legal WebTV Network LLC, LegalView.com, and LegalWebMedia.com are group advertising sponsored by the attorneys identified here. It is not a lawyer referral service. If you submit information on this website [more...]

Legal WebTV Network LLC, LegalView.com, and LegalWebMedia.com are group advertising sponsored by the attorneys identified here. It is not a lawyer referral service. If you submit information on this website, LegalWebMedia.com will submit your information to the law firms that pay for this group advertising and to respond to your requests for information concerning legal services in their assigned local areas. If there is no sponsoring firm in your state, your inquiry will be submitted to one of the sponsoring law firms on a predetermined, rotating basis. If the sponsoring law firm accepts your case, it will associate with licensed attorneys practicing in your state, if required; the sponsoring law firm may also contact other law firms to see if they may be able to assist.

The information provided by the LegalView.com and LegalWebMedia.com websites is for advertising and informational purposes and should not be considered as legal advice from the sponsoring attorneys. The websites contain general information and may not reflect current legal developments, verdicts, or settlements. LegalView.com contains information created by others or supplied through open forums; the sponsoring law firms are not responsible for the accuracy of this information. Any person viewing or receiving information from these websites should not act or refrain from acting on the basis of any such information without first seeking appropriate legal advice from an attorney in your area. Legal WebTV Network, LLC expressly disclaims any liability with respect to actions taken or not taken by the recipient based on any or all of the information or contents contained in these websites.

Any information sent to Legal WebTV Network LLC through this website is done using standard Web encryption techology. LegalView.com will exercise all reasonable care, within technological limits, to protect the confidentiality of any information submitted via Internet e-mail or through this website. By accessing this website, you may be seeking an attorney to represent you or legal advice. However, none of the sponsoring attorneys represent you yet.

The choice of a lawyer is an important decision and should not be based solely upon advertisements.

Any transmission of information, whether via Internet e-mail or through the website, is solely for evaluation purposes by the sponsoring law firms and their associates. The transmission of any information to any attorney sponsoring advertising on LegalView.com or LegalWebMedia.com does not create an attorney-client relationship between the sender and any recipient. An attorney-client relationship can only be created by a written, signed-fee agreement entered into with an attorney. The sponsoring attorneys will treat your information as a confidential communication for the purpose of obtaining legal services or legal advice.

For more information about the sponsoring law firms, please click here.

This form is secure and encrypted. More information about secure forms and your privacy here.