Clinical Research Regulatory Update: FDA Proposes Updates To Informed Consent Regulations, Issues Guidance On IRB Continuing Review

by Amy DowLeah Kendall and Lee Rosebush

February 2010


The U.S. Food and Drug Administration (“FDA”) continues to focus on clinical research activities. In this regard, FDA recently has taken two additional actions to regulate the conduct of clinical trials: (1) publishing a proposed rule updating informed consent regulations; and (2) issuing a draft guidance addressing Institutional Review Board (“IRB”) continuing review requirements. This Client Alert provides a high level summary of these recent FDA regulatory developments in the clinical research area. 

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NY Governor Paterson Introduces Bill Related To Interactions Between ‘Pharmaceutical Companies’ And Health Care Professionals

by Sarah Giesting and Wendy Goldstein

January 2010


On January 19, 2010, New York Governor David Paterson introduced Senate Bill 6608[i]as part of the 2010-11 New York State Executive Budget. Included in Senate Bill 6608 is a provision to add Section 279, “Interactions Between Pharmaceutical Companies and Health Care Professionals,” to the Public Health Law (“Section 279“). Similar bills are pending in the New York Senate and General Assembly.[ii]

If enacted, Section 279, like other current state marketing laws[iii] and industry codes,[iv]provides a code of conduct applicable to “all companies that sell or market prescription drugs, biologics or medical devices in the state” (“Pharmaceutical Company“).[v]Notably, Section 279 would be the first state law also to provide a code of conduct applicable to health care professionals (“HCP“) practicing in the state to whom such drugs, biologics or medical devices are sold or marketed.

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New Jersey Enacts Legislation Providing Job Protections To Volunteer Emergency Responders

January 2010


On January 14, 2010, acting Governor Steven M. Sweeney signed into law the New Jersey Emergency Responders Employment Protection Act. The Act prohibits employers from terminating, dismissing or suspending an employee who fails to report for work because he or she is serving as a “volunteer emergency responder” who is either: (1) actively engaged in responding to an emergency alarm; or (2) volunteering as an emergency responder during a state of emergency declared by the President of the United States or the Governor of the State of New Jersey. The Act will take effect on April 1, 2010.

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Lidings is becoming the partner of choice for businesses throughout Asia, Europe, and the United States

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New Statistics: Part-Time Lawyers Are Small in Number and Mostly Women

I just read a new press release by the National Association for Law Placement (NALP) that I would like to share with you. Entitled “Most Lawyers Working Part-time Are Women – Overall Number of Lawyers Working Part-time Remains Small,” the release highlighted statistics featured in the 2009-2010 edition of the NALP Directory of Legal Employers. NALP discovered that 5.9 percent of lawyers worked part-time in 2009, up from 5.6 percent in 2008. This information was based on data from 1,475 individual law offices and firms and more than 140,000 lawyers. (By the way, the percentage of part-time lawyers is far below the percentage of part-time employed individuals in the U.S. workforce as a whole, which was estimated to be nearly 14 percent in 2008.)

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Lidings’ attorneys have defended interests of Taiwanese company ASUSTeK in the Federal Antimonopoly Service (FAS)

Several leading manufacturers of notebooks sold throughout Russia (Асеr, ASUSTeK Computer Inc., Dell, Hewlett-Packard, Samsung Electronics, and Toshiba) were faced with an investigation by the Russian Federal Antimonopoly Service (FAS) in June 2009.

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Two Surveys Look at the Number of Women Partners at Law Firms

As 2009 draws to a close, I’ve noticed a proliferation of annual surveys. Two, in particular – one by The National Law Journal (NLJ) and the other by Law360 – captured my attention because they’re focused on the number of women partners at law firms. The survey results were a mixed bag. While the number of women partners rose slightly in 2009, only 18.47 percent of all partners are women, according to the NLJ. In the article “Women Still Number Too Few in Partner Ranks,” Law360 expressed concern that while women make up approximately half of law school graduating classes, many women are “leaking out” of the pipeline, whether due to family reasons or unfair stereotypes. However, Law360 also pointed out that some corporate clients are applying pressure on law firms to become more diverse, which will benefit women attorneys. 

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Update: Section 5 Transmission Inquiry Suspended

Following up on an earlier blog post, on Tuesday, the Minister of Energy, Mines and Petroleum Resources sent a letter to the British Columbia Utilities Commission advising it that the Section 5 Transmission Inquiry has been suspended until May 31, 2010.

Here is a copy of the Minister’s letter to the BCUC.

As the Minister explains in his letter, the reason for the suspension is in part due to the role of the Green Energy Advisory Task Force which is currently sitting and the Government’s consideration and policy responses to the impending recommendations from the Task Force as they relate to the development of the electricity industry and thus, BC’s long-term transmission and generation infrastructure needs.
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Update: Public Submissions Invited by Green Energy Advisory Task Force

The BC Government announced today that it wants to hear from the public about its ideas on the future of clean and renewable energy in British Columbia.

The Green Energy Advisory Task Force met for the first time over two days at the end of last week and it now invites submissions from the public on any of the four task force groups topics:

  • clean energy procurement and regulatory reform;
  • carbon pricing, trading and clean energy export market development;
  • community engagement and First Nations partnerships; and
  • clean energy resource development.
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BC’s Green Energy Advisory Task Force

Following up on the BC Government’s August 2009 throne speech and the Premier’s announcement on November 2, 2009, today, the BC Government announced the members of, and the terms of reference for, BC’s Green Energy Advisory Task Force.

Here is the weblink for public submissions, which can be made on any of the four task force topics until December 31.
I am very pleased to have been appointed to be a part of a team that will advance BC’s long-term vision for green energy.
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