Events

  • What Management and Marketers should know about the Amarin Off-Label Case & what it means for marketing

    Tuesday, October 27, 2015 8:30am - Tuesday, October 27, 2015 10:00am
    Category: Seminars
    Presenter: Mark DuVal
    Register:

    Join Mark DuVal for a seminar on recent regulatory-related rulings, and the effect they will have on the affected industries.

    Topics to be covered include:

    •  The U.S. Supreme Court speaks Sorrell vs. IMS Healthcare, Inc.
    • The 2nd Circuit weighs in Caronia and Amarin Pharmaceuticals and soon Pacira Pharmaceuticals
    • Where are the FDA and the Department of Justice at in all of this?
    • How do these cases impact government theories going forward?

    and more...

  • Smoldering Submission Issues: 510(k), PMA and DeNovo

    Tuesday, October 28, 2014 9:00am - Tuesday, October 28, 2014 12:00pm
    Category: Seminars
    Presenter: Mark DuVal

    DuVal & Associates and Medical Alley Association are pleased to offer a full-day program covering smoldering topics relating to submissions work, focusing on 510(k), PMA and De Novo.  These are current issues that everyone is asking questions about, and require group dialogue.  Our format will be to address each topic area, leaving time to fully engage the audience and our experts. The program will conclude with an open Ask-The-Experts interactive question and answer session.

  • Helping FDA Clear Your 510(k): Understanding FDA's Wants & Needs

    Thursday, October 16, 2014 7:30am - Thursday, October 16, 2014 5:00am
    Category: Seminars
    Presenter: Mark DuVal
    Organizer: DuValEDU

    Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary time and expense. Mark DuVal, a national authority who speaks and writes frequently on the 510(k) program is in Silver Spring, Maryland at FDA two to three times a month negotiating Pre-Submission, IDE, 510(k), de novo, PMA and combination product issues, as well as planning and executing panel meetings for his clients.  He has also filed a Citizen Petition with FDA trying to influence FDA’s administration of the 510(k) program.  This event will help attendees have a more solid foundation for understanding the 510(k) program while giving them the tools and insights, tips and tricks needed to obtain a 510(k) that is more likely to get cleared in a timely fashion. 

  • Helping FDA Clear Your 510(k): Understanding FDA's Wants & Needs

    Thursday, April 3, 2014 7:00am - Thursday, April 3, 2014 5:00am
    Category: Seminars
    Presenter: Mark DuVal

    Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary time and expense. Mark DuVal, a national authority who speaks and writes frequently on the 510(k) program is in Silver Spring, Maryland at FDA two to three times a month negotiating Pre-Submission, IDE, 510(k), de novo, PMA and combination product issues, as well as planning and executing panel meetings for his clients.  He has also filed a Citizen Petition with FDA trying to influence FDA’s administration of the 510(k) program. 

The information on our site is not intended to provide specific legal advice.

Helping clients be appropriately aggressive, yet compliant.™