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Our Speeches & Articles are designed as a resource for you on the wide variety of FDA legal topics and issues that
we have spoken or written about during the past few years. The presentations/articles are listed in chronological
order with the most recent first. Not all presentations are listed here. If you don't see the topic you are interested
in, check the complete list of all our past presentations, available here.
To locate information on a topic of interest, click on one of the TOPICS under Archives listed to the right on this
webpage and you will be taken to a list of downloadable presentations and articles on that Topic. To
view/download an article or presentation, just click on its title!
we have spoken or written about during the past few years. The presentations/articles are listed in chronological
order with the most recent first. Not all presentations are listed here. If you don't see the topic you are interested
in, check the complete list of all our past presentations, available here.
To locate information on a topic of interest, click on one of the TOPICS under Archives listed to the right on this
webpage and you will be taken to a list of downloadable presentations and articles on that Topic. To
view/download an article or presentation, just click on its title!
Upcoming Presentations
Recent Presentations and Articles
ARCHIVES
Our Archives contain past presentations
and articles organized by subject area.
Just click on the Topic Heading below
that matches the subject that interests
you and you can obtain full text copies,
on-line, of past presentations and
articles on key FDA regulatory law
issues.
and articles organized by subject area.
Just click on the Topic Heading below
that matches the subject that interests
you and you can obtain full text copies,
on-line, of past presentations and
articles on key FDA regulatory law
issues.
TOPICS
The de novo 510(k) Process -- The Impact of the New 2011 FDA Guidance. FxTranslations
Audio Conference. February 15, 2012.
Biosimilars -- Wave of the Future or Child of The Privileged Few? Licensing Executives
Society San Diego Chapter. February 21, 2012.
How Do You Look in Stripes? FDA Enforcement Today. Joint FDA/Orange County
Regulatory Affairs (OCRA) Annual Conference. June 7, 2012. Irvine, CA.
FDA Enforcement. Pre-conference Tutorial at DIA Annual Conference. June 24, 2012.
Philadelphia.
Leaping the Valley of Death: Keys to Successfully Going From the Lab to the Clinic for
Pharmaceutical Products. Drug Information Association (DIA) Annual Conference, Session
Chair. June 25-28, 2012. Philadelphia.
Audio Conference. February 15, 2012.
Biosimilars -- Wave of the Future or Child of The Privileged Few? Licensing Executives
Society San Diego Chapter. February 21, 2012.
How Do You Look in Stripes? FDA Enforcement Today. Joint FDA/Orange County
Regulatory Affairs (OCRA) Annual Conference. June 7, 2012. Irvine, CA.
FDA Enforcement. Pre-conference Tutorial at DIA Annual Conference. June 24, 2012.
Philadelphia.
Leaping the Valley of Death: Keys to Successfully Going From the Lab to the Clinic for
Pharmaceutical Products. Drug Information Association (DIA) Annual Conference, Session
Chair. June 25-28, 2012. Philadelphia.
Crisis Management for Regulatory Professionals. Regulatory Affairs Professionals Society,
Rising Leaders Program. Audio Conference. December 15, 2011.
FDA Enforcement Activities In Clinical Trials Arena. FxTranslations Audio Conference.
November 3, 2011.
Get to the Clinic on Time. LARTA NIH-CAP Commercialization Workshop, November 1,
2011. Los Angeles.
Rising Leaders Program. Audio Conference. December 15, 2011.
FDA Enforcement Activities In Clinical Trials Arena. FxTranslations Audio Conference.
November 3, 2011.
Get to the Clinic on Time. LARTA NIH-CAP Commercialization Workshop, November 1,
2011. Los Angeles.
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