Health

Complying with FDA’s Most Recent Guidance Webinar Nov. 13, 2020

Leave a comment


WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Drug, Biologics and Combination Products Labeling:

Complying with FDA’s Most Recent Guidance

An FDAnews Webinar

Friday, Nov. 13, 2020, 11:00 a.m. -12:00 p.m. EST

https://www.fdanews.com/druglabeling

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

What is needed to modify the content and format for IFUs?

Alan G. Minsk, Esq. — a Partner and Leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP — will clarify the 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  • Why FDA issued the draft guidance and its importance to regulatory, quality and compliance specialists, including the content and format concerns of FDA in general and details necessary for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 FDA considers to be “clear, concise information that is easily understood,” attend this webinar. One’s 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:

Drug, Biologics and Combination Products Labeling:

Complying with FDA’s Most Recent Guidance

An FDAnews Webinar

Friday, Nov. 13, 2020, 11:00 a.m. -12:00 p.m. EST

https://www.fdanews.com/druglabeling

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/druglabeling

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

Share article on social media or email:

Leave a Reply