New Rules for FDA Regulation of Lab Developed Diagnostic Tests (LDT)
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The questionable assay was a laboratory-developed test, which means vitro diagnostic test that is designed, manufactured, and used within a single laboratory. Laboratory-developed tests exist in a regulatory crevice. Because of its broad statutory authority over products intended for use in the diagnosis of disease or other conditions, the FDA considers laboratory-developed tests under its jurisdiction. Recently, however, the FDA has expressed concern with the proliferation of laboratory-developed tests, their marketing, and their potential to mislead physicians and patients and undermine clinical care. On July 31, 2014, the agency notified Congress that the agency would shortly release a draft guidance document containing a framework for the application of agency standards for quality, safety, and validity to laboratory-developed tests. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
On September 30, the agency posted the draft guidance document to its website and opened a comment period lasting until February 2, 2015. The agency will hold a public meeting on the topic on January 8 and 9, 2015, at the National Institutes of Health in Bethesda, Maryland. In this webinar speaker Mukesh Kumar speaks about updated FDA rules and regulations of Lab Development Diagnostic Tests and labeling, marketing practices. This webinar will discuss the current rules and practical tips for being compliant. The instructor will also provide advice based on his extensive regulatory experience on the best and worst case scenarios for various kinds of LDTs under the current regulations. The presentation is intended for general instructions to all LDT providers such as laboratories, clinics, physicians, hospitals, reimbursement experts, clinical trial users, and regulators who wish to have a better understanding of how FDA intends to regulate LDTs.
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.
Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit:
Senior management of LDT providers Project Managers Regulatory Vice Presidents, Directors and Managers Lab testing professionals Compliance professionals Auditors Attorneys - In-house or Outside Counsel
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Live Session - How it works
Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf formate will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Get certification of attendance.
Recorded Session - How it works
A link will be provided to you upon purchase of the recorded session Please click on the link to access the session Presentation handouts in pdf formate will be mailed to you Get certification of attendance.
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com