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NEJM Perspective — 23andMe and the FDA
23andMe and the FDA George J. Annas, J.D., M.P.H., and Sherman Elias, M.D. N Engl J Med 2014; 370:985-988March 13, 2014DOI: 10.1056/NEJMp1316367 “Because of the company’s aggressive marketing and refusal to resolve outstanding data...
Read MoreNEJM — Global Supply of Health Professionals
Nigel Crisp, M.A., and Lincoln Chen, M.D. N Engl J Med 2014; 370:950-957March 6, 2014DOI: 10.1056/NEJMra1111610 “Innovations in Learning We are at the leading edge of a wave of innovations in the education of...
Read MoreNEJM — Republican Health Care Proposal
Perspective Beyond Repeal — A Republican Proposal for Health Care Reform Timothy Stoltzfus Jost, J.D. N Engl J Med 2014; 370:894-896March 6, 2014DOI: 10.1056/NEJMp1401212 “… three Republican senators — Orrin Hatch (UT), Tom Coburn...
Read MoreMore than half of U.S. states have restrictions on a woman’s right to die, if pregnant .
” Kentucky’s attorney general, for example, advises that ‘the effectiveness of a Living Will is suspended during pregnancy.’” Perspective Death in Pregnancy — An American Tragedy Jeffrey L. Ecker, M.D. N Engl J Med 2014;...
Read MoreVirginia Federal Court approves service by Facebook, LinkedIn
The court finds that service of process on defendant by email and social networking websites identified by defendant as belonging to him complies with both Rule 4(f)(3) and constitutional due process. Plaintiff WhosHere, Inc....
Read MoreNIH, Industry and Non-Profits Partner to Speed Validation of Disease Targets
NIH, 10 biopharmaceutical companies and several nonprofit organizations launched an unprecedented partnership on Feb. 4 to transform the current model for identifying and validating the most promising biological targets of disease for new diagnostics...
Read MoreCOMPANY MUST BE IN GOOD STANDING TO MAINTAIN GOVERNMENT CONTRACT LITIGATION
Judge Sheridan notes “In order to maintain this action and for the Board to have jurisdiction over this case, Western States needs to be an LLC in good standing in Delaware, its state of...
Read MoreA Guide to FDA Postmarketing Submission Requirements and Reporting Interactive Promotional Media
From MintzLevin “The FDA’s proposed guidance provides for different treatment of different types of Applicant use of Interactive Promotional Media. The chart below (ON SITE) provides a visual breakdown of the treatment of each...
Read MoreAnswers To Common Questions About Abusive Patent Litigation
In June 2013, President Obama ordered the creation of this website to empower those who have received a demand letter or may be threatened with a patent lawsuit with information about their options. In...
Read MoreDigital Privacy Notice Challenge
Through the HIPAA Privacy Rule<http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/>, patients have the right to be informed of their rights with respect to their protected health information as well as how their health care providers and health plans may...
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