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Message from the Editor Don’t be bashful! You are a valued asset to your profession and your intellectual contributions would be welcomed in a heartbeat. If you have a little ditty, something from your professional regulatory experience that you would like to share and believe would be of benefit to our members, please forward it to my attention. All inputs need to be received by no later than the 28th of the month in order to be considered for the next newsletter. Thanks for your support, Paul Kramsky Message from the OCRA President Hello OCRA Members, We have received positive feedback from some of you regarding the newsletter…keep the comments coming so that we can better serve you. There was great attendance and interest at our recent “Latin American Regulations” conference – thanks to those of you who were able to attend! And, please remember to consider the November 16th conference on A Global Strategy for Clinical Studies: Understanding the Regional Regulations and Challenges. OCRA is also actively seeking potential collaborations with RAPS, Advamed, UCI, USC and other organizations to continue to provide our membership with excellent educational opportunities and benefits. Again, remember to le t us know your comments and also visit the OCRA webpage for the latest details (www.ocra-dg.org). Barbara Niksch Message from the Director FDA - Los Angeles District Office Have you noticed the rapidly increasing number of reality shows on TV? It’s gotten so bad, there are even reality shows about reality shows. It makes me wonder what is truly reality and what isn’t. One of the many challenges we face as regulators is to separate reality from fantasy.
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of the products it regulates and for speeding innovations that can improve public health. In the real world, manufacturers for the most part are conscientious about producing safe and efficacious products. However, without management commitment and a keen attention to quality, manufacturers can easily stray. This can lead to problems, which tend to mount, often resulting in an unwelcome visit from Big Brother. While we are from the government, we are not exactly here to help you, but to determine if you have adequate systems and controls in place and conclude if you need an Extreme Makeover. There will be some manufacturers for which voluntary compliance is not an option. This is because the Quality Manager, striving to be a Survivor, can’t risk telling the CEO that a new product can’t be launched for fear of feeling like being in the boardroom of The Apprentice and hearing those dreaded words “You’re fired!” Unfortunately, the consequences are that an Amazing Race ensues in which FDA and manufacturers engage in a protracted journey filled with inspections, meetings, warning letters and more meetings. The reality is that the public ultimately suffers because of the introduction of potentially harmful products. The bottom line is that FDA and manufacturers share the same mission -- assuring the safety, efficacy, and security of healthcare products and speeding innovations that can improve public health. And that my friends is the truest reality of them all! Alonza Cruse FYI – You will have the opportunity to meet our new District Compliance Director, Pamela Schweikert. Pam joined FDA as an investigator in the Los Angeles District in 1983 and returned to the district in April of this year as it’s new Compliance Director after serving in various compliance capacities within the Agency. Pam also received an individual Commissioner’s Special Citation for her 2001 work on an ephedrine dietary supplement case and new medical gas regulations. You can meet Pam on Thursday, November 11, 2004 in a program being sponsored by the San Diego Regulatory Affairs Network (SDRAN). For more information, go to www.sdran.org. Update on Programs The October 19 program on Latin America Regulations was very successful and well attended (over 50 attendees). To those who did not make it -- You missed a lot! The speakers guided us through the process and let us know some of the hurdles to getting products approved south of the US. The process is not as complicated as some thought and in fact one set of documents may be used for many of the countries. Lots of good information transfer. Perhaps we'll see you at the November meeting. Coming in November November 16 – A Global Strategy for Clinical Studies: Understanding the Regional Regulations and Challenges This program is a full-day seminar intended to provide a general understanding of the regulations, standards and best practices for clinical studies in the US, Canada and Europe as part of a series of programs on conducting clinical trials throughout the world. The meeting will focus on clinical studies for product approval and registration with presentations from the US FDA, Canadian Ministry of Health, members of the ICH and standards committees, clinical research organizations and study sponsors. There will be interactive opportunities for questions and answers and discussions with the presenters and other meeting attendees. Register early to reserve your place; to register, go to our website at www.ocra-dg.org. We hope to see you there. 2005 ProgrammingPrograms on global initiatives for the regulation of medical devices featuring prominent FDA’ers and marketing and regulatory strategies for venture-backed start-up companies are planned for the 1st Quarter of 2005. The best programs are born because of your participation and valued input, so we encourage you to help us with planning the remainder of the 2005 programs by forwarding your ideas for monthly meeting topics to Rusty Lusk at qualitysys@sbcglobal.net.For more information, visit our web site at www.ocra-dg.org and stay informed. Rusty Lusk Other Educational Opportunities UC Irvine Extension’s Medical Product Development Program UC Irvine Extension's Medical Product Development program offers a comprehensive body of knowledge in medical product compliance, design and development. Learn what it takes to take your product from concept to market. The Clinical Trials program provides practical knowledge to healthcare professionals involved in clinical trials for the development of medical products. For more information, visit the website at, http://unex.uci.edu/courses/certificate/certificate8.asp. FDA Center News This section will provide OCRA members with news of recently issued guidance documents. The following new guidances were announced in the Federal Register in October. OCRA wishes to thank Trudy Papson, a Consumer Safety Officer in the Los Angeles District, and Helene Spencer, past President of OCRA, for contributing to this section. From CDRH “Implementation of the Inspection by Accredited Persons Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria”. This guidance contains important information regarding the conduct of third party inspections of eligible Class I, Class II and Class III medical device firms as an alternative to FDA inspections. Visit CDRH’s website at http://www.fda.gov/cdrh/guidance.html to review this guidance. If you want to provide comments on this guidance, or to discuss the guidance with the goal of jointly issuing comments, please contact Helene Spencer at spencer@genyx.com. From CDER "Guidance for Industry: PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance." The guidance explains a science and risk-based framework for "Process Analytical Technology, or PAT." To read the guidance, go to: http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0380-gdl0002.pdf "Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice." This guidance explains CDER's current thinking on manufacturing of sterile drug products produced by aseptic processing in the context of complying with certain sections of the current good manufacturing practice (CGMP) regulations for drug and biological products. To read the guidance, go to: http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0380-gdl0002.pdf From CBER "Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information. The guidance document provides to vaccine manufacturers, medical practitioners, and consumers an overview of the vaccine labeling review process. To read the guidance, go to: http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0414-gdl0001.pdf. New Draft Guidances "Current Good Manufacturing Practices for Combination Products." Once finalized, this guidance will provide guidance to industry and FDA staff on the applicability of current good manufacturing practices (CGMP) for combination products. To read the draft guidance, go to: http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0431-gdl0001.pdf. "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations." This draft guidance, announced by CDER, CBER, CVM and ORA, describes the key elements of a robust quality systems model and shows how persons implementing such a model can achieve compliance with the CGMP regulations To read the draft guidance, go to: http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0443-gdl0001.pdf. "Computerized Systems Used in Clinical Trials." This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to FDA. To read the draft guidance, go to: http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0440-gdl0001.pdf. Regulatory Tidbits This month’s newsletter continues the theme from last month’s newsletter pertaining to the establishment of a documented and controlled process for determining when a change is significant or not. We believe that regulatory assessments of changes should be driven in large part by the risk associated with the change. As such, we recommend that companies align their regulatory decision-making processes with their risk management decision-making processes.
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