• Regulatory Pains

    • On: October 16, 2013 at 08:10AM
    • Category: Conferences

    The MichBio Expo is the largest gathering of bioscience professoinal in Michigan, and MichBio as the industry trade association, endeavors to bring the most timely topics and experts to insure a top-notch program. This year, the theme is 'Bio-Growth through Bio-Innovation', and our Keynote Speaker will be Stelios Papodopoulos, PhD. Chairman of Exelixis. In additiong, the event will feature a Bio-Industry Town Hall, CEOs Unplugged session, multiple track sessions, facility tours, and a Biosciences Emerging Showcase for start-ups seeking investment.

  • 510(k) Delays: Is it FDA or Quality?

    • On: May 2, 2013 at 12:05PM
    • Category: Conferences

    MedCon 2013, Xavier University, Cincinatti, OH.

    Industry has ongoing concerns that the 510(k) review process continues to delay approvals and stifle innovation. This session will discuss FDA's recently released refusal to file guidance and common quality issues with 510(k) submissions. The discussion will include FDA performance metrics under the current regulations and changes implemented with MDUFMA III. An industry perspective will be presented using representative case studies.

  • Strategies for the 510(k) Pathway: Submission and Approval

    • On: February 12, 2013 at 01:02AM
    • Category: Conferences

    Strategies for the 510(k) pathway: Submission and Approval. This conference is presented in Orange County, California.

  • Update on 510(k) Changes: Timeline for Implementation and Assessment of Effects on Industry

    • On: October 15, 2012 at 11:10AM
    • Category: Conferences

    Update on 510(k) Changes: Timeline for Implementation and Assessment of Effects on Industry

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