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Life Sciences, Technology and Economic Development: The Massachusetts Model
Representative Daniel Bosley
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Abstract:
The adage "to whom much is given, much is expected" applies to Massachusetts when speaking about Life Sciences, Technology and Economic Development. Massachusetts is fortunate to have key intellectual assets within its boundaries. The state claims the top 5 NIH funded research hospitals a total of 122 colleges and universities, and ranks first among states in percentage of residents with Bachelor of Arts degree or higher. Massachusetts has achieved biotech industry prominence from its fortuitous trifecta of world class academic institutions, major teaching hospitals and a well-financed venture capital community. Massachusetts' Biotech industries rely on collaboration, a key pillar of scientific discovery. The legislature contributes to this collaboration through various forms of legislation such as the most recent Economic Stimulus Package. By extending collaboration from the biotech industries to the state government, Massachusetts can claim some distinct success thus far. This article discusses the unique factors that have positioned the Commonwealth of Massachusetts as a leader in the life sciences.
4 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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New Products, New Challenges, New Opportunities: Building Sales and Marketing Communications Compliance
Glen T. Giovannetti and Ted Acosta
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Abstract:
In an environment of new product approvals and increasing regulatory scrutiny, biotech companies are increasingly challenged to build cultures of compliance around sales and marketing communications. While it's impossible for companies to put compliance executives on the front line alongside sales representatives and physicians in the field, it is on the front line that many of the breakdowns in compliance take place. At many life science companies, internal audit and the finance organizations are becoming involved in communications compliance, bringing the opportunity for new dimensions beyond assessment and implementation of policies and procedures. A monitoring and auditing framework can be established to regularly review both the information that is being communicated, as well as to whom it is targeted. For biotech companies that approach the issue strategically, compliance can be not just an obligation, but also an opportunity for achieving competitive advantage.
3 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Additional Insured, Additional Risk
Todd S. Schenk and Erin L. Majka
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Life sciences organizations should carefully weigh both the value and the risks of giving additional insured status to a business partner. While the third party may obtain great benefits by being made an additional insured, the insured is assuming great risks. This article highlights the issues associated with this practice.
4 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Inert Pesticide Ingredient Regulation: Legal and Policy Considerations
Kelly M. Hogan & Bryan A. Liang
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Inert ingredients in pesticides have significant safety issues, yet the current legal infrastructure provides limited safety information and dissemination to consumers. This paper provides an overview of regulations governing inert ingredients and highlights key opportunities for improvement. Using a policy building upon government and industry cooperation and EPA policy changes, a legal infrastructure that promotes consumer safety, knowledge acquisition, and manufacturer development of improved pesticides can be accomplished.
6 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Human Stem Cell Research in Israel: The Scientific, Ethical and Regulatory Framework
Janet Zoldan and Shulamit Levenberg
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Abstract:
Recent developments in human stem cell research (hESC) have raised hopes of discovering new cures for various illnesses and to alleviate human suffering. At the same time, these developments raise important issues about the ethics of such research. Each country has addressed these issues according to its cultural, political, and religious perspectives. This article summarizes the position that various religions adopted regarding hESC research and focuses on policies in Israel.
5 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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The Regulation of Medical Devices and the Worldwide Scene
Larry Kessler
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Abstract:
U.S. medical technology companies lead the world, producing nearly $78 billion annually and generating nearly 6% annual growth. While this is impressive enough, it pales in comparison beside the value of the medical devices that are ubiquitous in our health care, and increasingly our home, environment. This article discusses critical aspects of the FDA regulatory system for medical devices and provides an overview of the global regulatory landscape.
3 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Regulation of Medical Devices: Past, Present, Future
Daniel G. Schultz
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Abstract:
The regulation of medical devices requires a unique blend of science, law, public health policy, and common sense. This has posed an enormous challenge to both the Food and Drug Administration (FDA) and the industry since the passage of the Medical Device Amendments in 1976, and it has led to a complex and ever-evolving regulatory system designed to accommodate a very broad range of products. This article is an attempt to describe that evolution and to offer some thoughts on what the future may hold.
6 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Combination Products: Challenges and Progress
Mark D. Kramer
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Abstract:
Combination products raise a variety of regulatory and review challenges. Though the United States (US) regulation of drugs, devices, and
biological products share many of the same basic features, they are also each somewhat unique. Drugs, devices, and biological products each have their own types of marketing applications, good manufacturing practice regulations, and adverse event reporting requirements. When drugs and devices, drugs and biologics, or devices and biologics are combined to create a new product, questions are sometimes raised about how the combination product as a whole will be regulated. For example, there is no special type of marketing application for combination products. Furthermore, although one Center will lead the premarket review, consultation is frequently required with another Food and Drug Administration (FDA) Center. This article highlights the existing regulatory process for emerging combination products.
4 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Emerging Role of Risk Management in Medical Device Development
William Midgette, Alford Taylor and Alfred M Dolan
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For almost twenty years, medical device manufacturers performed risk analyses for their devices. Far too often, these risk analyses were not performed during development but retrospectively to simply meet regulatory reporting requirements. When these analyses revealed problems that had to be corrected, corrections were made often with greater difficulty and cost than if they had been identified earlier in the development process.
Over the past decade, the importance of a proactive approach to managing risk has emerged. This article discusses quality assurance and risk management practices.
3 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Postmarket Surveillance: Ensuring the Safety of Marketed Medical Devices
Thomas P. Gross and Susan N. Gardner
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Abstract:
The Food and Drug Administration (FDA) requires that medical devices be reasonably safe and effective prior to marketing. "Reasonably safe," however, is not synonymous with risk free. The agency, therefore, approves a device when it deems that the product's benefits outweigh its risks for the intended population and use. Because no device is free of adverse events and product problems and because premarket clinical data are limited, postmarket oversight is needed as a "safety net" to assure the continued safety and effectiveness of marketed products. Postmarket oversight refers to postmarket surveillance and risk assessment as well as postmarket enforcement.
This article provides an overview of postmarket surveillance and regulatory requirements, existing monitoring and reporting "tools" as well as recent program and policy developments at the FDA.
7 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Basic Medical Device Regulatory Review Processes at the FDA: A Step-by-Step Approach for Early Stage Companies
John F. Stigi
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No Abstract
4 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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Radiofrequency Identification Technology: FDA Technical and Regulatory Perspective for Medical Devices
Ann Ferriter and Binita Ashar
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Abstract:
The FDA recognizes that there are benefits and risks of using Radiofrequency Identification (RFID) technology in a healthcare setting. This
article discusses the benefits and outlines efforts to minimize the electromagnetic interference risks. Awareness of the risks will help to ensure that RFID technology will be used safely in a healthcare setting.
3 pages
©2007
by The Journal of BioLaw & Business. All Rights Reserved.
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