Archives -- Research & Development

Articles

Profitability, Patient Populations and the Orphan Drug Act – or – “Should an Orphan Have the Right to More Than One Parent?”  Food, Drug, Cosmetic and Medical Device Law Digest, New York State Bar Association, Food, Drug and Cosmetic Law Section, January 1992.   Click here for article

Presentations & Panel Discussions

Latest Developments in and the Future of the Regulatory Landscape for Approving Treatments  for Orphan and Rare Diseases. Orphan Drugs & Rare Diseases -- 2018 Americas West Coast. June 25, 2018.  San Diego, CA.


Alternative Approaches to FDA Approval for Drug and Device Firms. Joint Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference. May 6, 2016. Irvine, CA. 


Alternative Approaches to FDA Approval for Drug and Device Firms. San Diego Regulatory Affairs Network. February 12, 2015. 


Alternative Approaches to FDA Approval for Drug and Device Firms. A Compliance2Go Webinar. January 29, 2015. 


Creative Strategies in Dealing with FDA for Approval of Drugs and Medical Devices.  PSC Creative Learning Webinar. July 10, 2013.


Alternative Approaches to FDA Approval for Drug and Device Firms.  Compliance2Go Webinar. February 21, 2013.


Leaping the Valley of Death: Keys to Successfully Going From the Lab to the Clinic for Pharmaceutical Products. Moderator.  Drug Information Association (DIA) Annual Conference, Session Chair.  June 26, 2012. Philadelphia. [no slides; moderated panel]


Regulatory Considerations in Product Development. LARTA NIH-CAP Commercialization Workshop, November 1, 2011. Los Angeles.


Regulatory Challenges in Executing Global Clinical Studies.  The Conference Forum’s 2nd Annual Executing Global Clinical Trials Conference.  September 15, 2011, Philadelphia.


The Top Ten Ways to Ensure Successful FDA Meetings.  Webinar. The Weinberg Group. March 2, 2009.


FDA Regulatory Considerations for the Biomedical Start-Up.  Israeli Life Sciences fellows Program, Merage Foundation. February 27, 2008, Irvine, CA.


FDA Regulatory Considerations for the Biomedical Companies. LARTA NIH-CAP Commercialization Training Workshop, October 17, 2007, Marina Del Rey, CA.


FDA Regulatory Considerations in Launching Products.  Women In Technology International (WITI) San Diego Conference, February 14, 2006, San Diego.


FDA Regulatory Considerations for the Biomedical Start-Up.  NIH-CAP Workshop, LARTA, October 7, 2005, Newport Beach, CA. 


For information on my services relating to the R&D phases of biomedical product development, ...