FDAnews Announces -- Labeling for Prescription Drugs, Biologics and Combination Products:Complying with FDA's Most Recent IFU Guidance Webinar, Oct. 29, 2019

What implications does the recent Instructions for Use (IFU) guidance have on new drug applications and biologics license applications?

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Retrieved on: 
Tuesday, October 15, 2019 - 5:00am
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Key Points: 
  • What implications does the recent Instructions for Use (IFU) guidance have on new drug applications and biologics license applications?
  • How will the current content and format for IFUs need to be modified?
  • a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP will clarify the new guidance and explain how to comply with it.
  • Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
    to learn about our special multisite discount.


FDAnews Announces -- Labeling for Prescription Drugs, Biologics and Combination Products:Complying with FDA's Most Recent IFU Guidance Webinar, Oct. 29, 2019

FALLS CHURCH, Va., Oct. 15, 2019 /PRNewswire-PRWeb/ -- Labeling for Prescription Drugs, Biologics and
Combination Products:
Complying with FDA's Most Recent IFU Guidance
**An FDAnews Webinar**
Tuesday, October 29, 2019, 1:30-3:00 p.m. EDT
https://www.fdanews.com/labelpredrug

What implications does the recent Instructions for Use (IFU) guidance have on new drug applications and biologics license applications?

How will the current content and format for IFUs need to be modified?

Alan G. Minsk, Esq. — a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP — will clarify the new guidance and explain how to comply with it.

During this webinar, attendees will discuss:

  • Why FDA issued the draft guidance and its importance to regulatory, quality and compliance specialists, including the content and format concerns of FDA in general and details necessary for safe and effective use
  • What kind of language IFUs should be written in to be patient friendly
  • What the guidance recommends in terms of voice, commands and sentences
  • Examples of sample labeling that covers all elements of an IFU from dosage and usage to storage and disposal
  • What kinds of recommendations FDA makes in terms of design and layout, such as the use of easy-to-read fonts, sequential numbering and white space
  • Some practical considerations on patient labeling, from a business perspective

If one is at all unclear how to implement this guidance and change IFUs to include what the FDA considers to be "clear, concise information that is easily understood," one must attend this webinar. NDAs and BLAs depend on it.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Labeling for Prescription Drugs, Biologics and
Combination Products:
Complying with FDA's Most Recent IFU Guidance
**An FDAnews Webinar**
Tuesday, October 29, 2019, 1:30-3:00 p.m. EDT
https://www.fdanews.com/labelpredrug?hittrk=19O15VOCUS [https://www.fdanews.com/labelpredrug __title__ Patient Prescription Labeling]

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/labelpredrug
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations

 

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