Title Date Authors Type Download
Legal Analysis: A Low Dose Prescription Dec 10, 2007 Michele L. Adelman, Catherine N. Karuga General Download

Criminal Prosecution of Off-Label Drug Promotion

SUMMARY

Drug company scientists discover that a rare debilitating disease may be treated with a drug licensed to treat an unrelated ailment. The Food and Drug Administration (“FDA”) has not approved the drug for the rare disease. While the company begins time consuming and expensive clinical trials to test this discovery, patients with the rare disease ask their doctor for the drug. Doctors seek as much information as possible on this “off-label” use. The drug company wants to get the word out quickly about the new use.

  • Should a drug company be permitted to promote the drug for the new use before FDA approval, and if so, what can the company say?
  • Should doctors be permitted to prescribe a drug for an unapproved use, and if so, under what conditions?
  • If doctors can prescribe the drug, how do they obtain information on the correct dosage and adverse side effects?
  • Under what circumstances can a company provide “off-label” information to doctors?

Download A Low Dose Prescription: Criminal Prosecution of Off-Label Drug Promotion (.pdf)

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Immigration Alert - November 8, 2007 Nov 8, 2007 Punam Singh Rogers Alert

USCIS Issues New I-9 Form

SUMMARY

On November 7, 2007, USICS issued a revised I-9 Employment Eligibility Verification Form. The primary change to the revised Form I-9 is the elimination of five documents which were previously listed on List A as acceptable for proof of both identity and employment eligibility:

  • Certificate of U.S. Citizenship (Form N-560 or N-570)
  • Certificate of Naturalization (Form N-550 or N-570)
  • Alien Registration Receipt card (Form I-151 - please note that the current I-551 Permanent Resident Card remains on List A)
  • Reentry Permit (Form I-327)
  • Refugee Travel Document (Form I-571)

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Doing Business in Massachusetts Aug 14, 2007 Arlene L. Bender, Michael N. Glanz eBook Download

A Guide to U.S. and Massachusetts Law for Non-U.S. Businesses

SUMMARY

This guide is intended to provide foreign businesspeople with an introduction to the basic kinds of laws and regulations that affect the conduct of business in the United States, and particularly in the Commonwealth of Massachusetts. The level of detail is varied, reflecting the nature of the legal areas discussed. For example, environmental law and taxation are subjects of detailed and technical regulation, while labor relations are governed as much by custom and practice as by direct regulation.

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State Farm Jan 1, 2004 David R. Geiger, Matthew C. Baltay General Download

Refining the Constitutional Limitations on Punitive Damages Awards

SUMMARY

The revocable trust established as a part of your estate plan can serve as a very useful asset management vehicle during your lifetime. The benefits of funding a revocable trust during lifetime include:

(a) To avoid probate and many of the attendant delays, costs and administrative hurdles which are often associated with probate
(b) To avoid public disclosure of the extent of the Donor’s assets and his dispositive plan by avoiding the filing requirements of the probate registry
(c) To secure professional investment management for the assets placed in the trust
(d) To provide for continuity of management of the assets and access to the assets in the event of the Donor’s incapacity or incompetence.

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