OCRA’s eNEWSLETTER                     August 2004

 

 

Message from the OCRA President

 

Hello OCRA Members,

 

I have started my term as the President of OCRA.  I am excited to take on this responsibility and to continue to work with the many volunteers on the board of directors.  My goals are to continue to build this organization and provide excellent educational opportunities for all members.  In addition, we will seek to continue collaborations with local universities and other national organizations.  The board of directors welcomes your comments and suggestions and also encourages all members to periodically visit the OCRA web page - http://www.ocra-dg.org.    As an organization based on volunteers, I thank you in advance for your help during the next year and I look forward to working with you!

 

~ Barbara Niksch

 

 

From Alonza Cruse, Director of FDA's Los Angeles District

 

FDA is that unique place where science and the law meet.  It's an institution that you either love or hate.  Through it all, we attempt to remain committed to our mission of public health protection.  I see OCRA as an equally unique place where ideas, suggestions, problem solving and the collaborative efforts of many strive for voluntary compliance in the drug, device biologics and biotech areas. The annual educational conferences which are co-sponsored by FDA and OCRA continue in that tradition of collaborative efforts.  Although planning takes many months, you get to know the folks involved, their drive and commitment to quality.  I can think of no better way to spend my time, than with these types of outreach and planning efforts. 

 

I commend OCRA on its leadership role with industry and continued growth and success as an organization. 

 

 

Dr. Del Stagg, Senior Director, Worldwide Regulatory Affairs, was honored at the 7^th Annual FDA/OCRA Educational Conference held in Irvine, CA

In June 2003, OCRA honored one of its founders and ardent contributors, Del Stagg, by providing an educational scholarship to the USC Master's of Regulatory Science Program in his name. Del exemplifies the spirit of educational service to the regulatory affairs community in Orange County and we were very pleased to honor him in this fashion. Read more about this award in an article written by John Spoden for the Allergan company newsletter. 

 

 

FDA has released a new guidance document for A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures - released on July 6, 2004

 

Complete guidance details are available at http://www.fda.gov/cdrh/ode/guidance/1347.html.

 

 

Schultz Appointed as Permanent CDRH Director

 

Dr. Daniel G. Schultz has been appointed director of the FDA's Center for Devices and Radiological Health (CDRH). Acting Commissioner of Food and Drugs Dr. Lester M. Crawford announced the appointment in a July 20 memorandum.

 

Schultz has served as CDRH's acting director since May 1 following the resignation of Center Director Dr. David W. Feigal Jr., who had served in the position since 1999.

 

"As Director ... Dan Schultz will continue to head up a strong management team -- providing continuity for CDRH's many programs and ongoing initiatives," Crawford said in the memorandum.

 

Before becoming acting CDRH director, Schultz was the director of the Center's Office of Device Evaluation (ODE), a position he assumed on Aug. 26, 2002. Previously at CDRH he served as deputy director for clinical and review policy at ODE, director of the Division of Reproductive, Abdominal and Radiological Devices, that division's chief medical officer and a medical officer in the Center's General Surgery Branch. Previously Schultz worked in the U.S. Public Health Service and at hospitals in Arizona, California, Colorado and New Mexico.

 

Schultz received his medical degree in 1974 from the University of Pittsburgh and is board certified in general surgery and family practice. He is a Fellow of the American College of Surgeons.

 

 

OCRA will present a one day program on 21 CFR Part 11, Electronic Records and Electronic Signature, on August 10, 2004 at the Marriott Hotel in Irvine.

The featured speaker is Joe Famulare, Chairman of FDA's Part 11 Working Group, who will provide the current status on FDA's policy and future of this important regulation. In addition, speakers from industry will present information on manufacturing information systems and clinical study databases. As you know, Mr. Famulare is FDA's leading expert on Part 11, so this will be your chance to address FDA and industry experts with your burning issues regarding Part 11 compliance. See the Meeting Brochure (website link) for additional information on speakers and meeting registration.

 

 

Volunteers are needed for an Industry Panel to discuss multi-national clinical trial experience at the OCRA Global Clinical Studies Workshop in October 2004.

If you or your company has clinical trial experience for drugs, devices or biologics in Europe, Asia, Canada, Austria or Latin America and your clinical data was supportive of FDA submissions, we would appreciate your participation in a Sponsor panel to discuss benefits and pitfalls of doing multinational studies. Please send an e-mail to spencer@genyx.com letting us know your availability to participate in this important discussion which will serve to benefit OCRA members.

 

 

Botox gets FDA approval as treatment for excessive sweating

 

The FDA has cleared Allergan's Botox use for excessive underarm sweating, or primary axillary hyperhidrosis. For details, go to http://www.msnbc.msn.com/id/5465784.

 

 

FDA has released a new guidance document on 7/12/04 entitled "FDA Export Certificates."

 

This guidance summarizes the documents required, activities involved and fees associated with the export of all medical products. A  copy of this document is available at http://www.fda.gov/cber/gdlns/exprtcert.pdf .

 

 

Waste and Europe- by: Christine Ruther

 

Elimination of waste generation from cradle to grave is a significant issue in Europe.  For an overview of the current status of affairs in this area, see Europa’s “Environment and Sustainable Development” webpage at http://europa.eu.int/comm/enterprise/environment/index_home/waste_management/waste_management.htm.

 

For Christine Ruther’s complete article on “Waste and Europe,“ please go to http://www.ocra-dg.org/waste.htm.

 

 

Upcoming AMDM Focus Meeting in San Diego – co-sponsored by SDRAN

 

This year, the Association for Medical Diagnostic Manufacturers has teamed with the San Diego Regulatory Affairs Network (SDRAN) to develop a program intended to address both the IVD and medical device segments of industry. Through technical sessions, IVD Focus XIII promises unique opportunities to concentrate on current and emerging issues and to learn about the latest regulatory changes. The presentations focus on FDA regulatory and quality topics that appeal to both the new and established diagnostic/biotechnology manufacturers needs. Subjects range from basic to advanced levels; from developing programs to special attention areas.  Presenters are from industry and FDA.  For more conference  information go to the AMDM website http://www.amdm.org/AMDM/092304-IVD-FocusXIII.html .