Life Sciences

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Subject Created By Replies Last Updated AUTO: Eve Ross/WLGORE (returning 02/19/2010) Eve Ross 0 2/19/2010 12:13 AM Fraud & Abuse Ann Timpe-Brennan 0 2/18/2010 5:12 PM BNA Life Sciences Law and Industry Outlook 2010 Magdalena Wencel 0 1/15/2010 3:26 PM Partners Imposes Pay Restrictions on Those Sitting on Boards of Biotech and Pharmaceutical Companies Peter Leibold 0 1/4/2010 11:01 AM Annual Meeting Luncheon Program Jennifer Geetter 1 1/4/2010 10:32 AM OIG saves almost 21 billion in FY09 Peter Leibold 0 12/4/2009 12:57 PM New Web address for IOM documents for clinical trial agreements and material transfer agreements Adam Rifkind 0 11/19/2009 8:22 AM GINA will take effect in the nation’s workplaces next weekend Alan Goldberg 0 11/16/2009 7:18 AM Doctor claims retaliation for not using stent Peter Leibold 0 11/12/2009 5:46 PM Virginia State Bar Lawyer Susan C. Winckler to Lead FDLI Organization, Effective November 6 Alan Goldberg 0 11/12/2009 1:10 PM HL7 Announces Industry’s First Electronic Health Record System (EHR-S) Functional Requirements Standard for Clinical Research Alan Goldberg 0 11/9/2009 6:41 AM GINA/Employers Rachel Nosowsky 0 11/5/2009 1:05 PM (no title) Pamela Emenheiser 0 11/1/2009 8:05 PM The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research Alan Goldberg 0 11/1/2009 6:36 PM Investigator Responsibilities Rachel Nosowsky 0 10/29/2009 2:09 PM Sen. Baucus: Doctors, Patients, and the Need for Health Care Reform Alan Goldberg 0 10/22/2009 6:27 AM Eve Ross/WLGORE Eve Ross 0 10/22/2009 1:01 AM It's all in the genes - Massive Gene Database Planned/California Alan Goldberg 0 10/21/2009 10:23 AM Clin Trial billing with mix of private/govt pay patients Lynne Rasmussen 0 10/20/2009 11:11 AM Traditional rules allowed applicants to file an unlimited number of continuing applications, requests for continued examination, and claims. Alan Goldberg 0 10/9/2009 12:17 PM Article on GINA Interim Final Rules Bianca Bishop 3 10/8/2009 9:25 AM Preliminary Analysis of the Chairman's Mark for the America's Healthy Future Act, as Amended - Wed Oct 07 Jayson Slotnik 0 10/7/2009 4:41 PM Clinical Trials: FTC - bloggers, endorsement, disclosures Alan Goldberg 0 10/6/2009 9:50 AM Combination Products Proposed Rule Peter Leibold 0 10/5/2009 5:10 PM Health risk assessments face genetic bias hurdle; GINA 2008, continued.... Alan Goldberg 0 10/2/2009 2:58 PM DOL The Genetic Information Nondiscrimination Act of 2008 (GINA) Alan Goldberg 0 10/2/2009 1:27 PM FW: HHS RELEASE--New Rules Protect Patients' Genetic Information Jayson Slotnik 0 10/1/2009 4:40 PM Bill Clinton to Address AdvaMed 2009 on October 14 Peter Leibold 0 10/1/2009 3:10 PM Inspector General Pat McFarland Peter Leibold 0 9/29/2009 4:28 PM Four Significant Antitrust Developments Peter Leibold 0 9/28/2009 5:31 PM Nelson PhRMA Amendment Fails Peter Leibold 0 9/25/2009 10:38 AM Life Science Amendments Highlight Finance Committee Mark Up Peter Leibold 0 9/23/2009 4:36 PM Prometheus Lab Decision: methods of treatment claimed in the patents in suit squarely fall within the realm of patentable subject matter Alan Goldberg 0 9/21/2009 6:18 AM Health Lawyers In Transition Alan Goldberg 0 9/20/2009 6:15 PM Chairman Baucus Mark Peter Leibold 0 9/17/2009 12:59 PM PhRMA/Physician Relationships and the proposed tax on Device Companies in the News Peter Leibold 0 9/15/2009 5:48 PM Today, its South Carolina and Lilly regarding off-label use Peter Leibold 0 9/9/2009 9:28 AM Loucks Confirmed for Life Sciences Law Institute Peter Leibold 0 9/8/2009 7:05 PM Pfizer Settlement may not deter practices Peter Leibold 0 9/8/2009 9:20 AM Forest Labs Payments to Doctors Questioned; Pitt and Researcher sued for alleged falsification Peter Leibold 0 9/4/2009 10:04 AM Pfizer settlement - Sending a Message Peter Leibold 0 9/3/2009 10:15 AM Bilski v. Doll, U.S. Supreme Court To Decide Alan Goldberg 0 8/31/2009 6:35 AM RE: Daily Digest for Life Sciences Robert Schwartz 1 8/26/2009 8:19 AM Suggested speakers regarding patents of genes Jennifer Geetter 0 8/25/2009 8:14 AM Pharmacies Sue to Block Pfizer Purchase of Wyeth Peter Leibold 0 8/24/2009 10:57 AM Life Sciences Law Institute Nearing Completion Peter Leibold 0 8/21/2009 5:50 PM Updates on EMTALA for a Disaster Peter Leibold 2 8/18/2009 3:21 PM State Laws Could Cover DTC Gene Testing Alan Goldberg 0 8/17/2009 6:37 PM Interesting take from the Gates Foundation on the Availability of Vaccines Peter Leibold 0 8/17/2009 10:58 AM NIH to Fund Bioinformatics Small Business Grants Alan Goldberg 0 8/12/2009 4:35 PM FDA Announcement Rachel Nosowsky 0 8/6/2009 12:21 PM Eve Ross/WLGORE Eve Ross 0 8/6/2009 1:03 AM Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age Alan Goldberg 0 8/5/2009 8:00 AM International Arbitration Rules Lynne Rasmussen 0 7/28/2009 11:59 AM Sharfstein addresses FDA's Ability to Budget for Needs Peter Leibold 0 7/21/2009 12:43 PM Intellectual Property Counsel on behalf of Generics and/or consumers Peter Leibold 0 7/14/2009 12:39 PM Dr. Sharfstein to keynote Life Sciences Law Institute Peter Leibold 0 7/14/2009 10:11 AM Issues to be addressed at Life Sciences Law Institute Peter Leibold 1 7/8/2009 9:36 PM Science and Technology Committee - Second Report Genomic Medicine UK House of Lords Report today Alan Goldberg 0 7/7/2009 11:29 AM Biotech companies fight with each other over the commercial rights to ideas and technology all the time. Patent lawsuits are as much a part of the business as lab work and clinical trials. Alan Goldberg 0 7/3/2009 6:59 AM $1.1 billion to fund "comparative effectiveness research" as part of the stimulus legislation this year - I have seen technology assessments make it more difficult Alan Goldberg 0 7/2/2009 8:01 AM Eve Ross/WLGORE Eve Ross 0 7/2/2009 1:04 AM CMS just put on display the proposed rule for CY 2010 Outpatient Prospective Payment System and CY2010 Ambulatory Surgical Center Payment System Jayson Slotnik 0 7/1/2009 5:21 PM CMS just relapsed the proposed physician fee schedule for 2010 Jayson Slotnik 0 7/1/2009 11:41 AM Patient-Centered Outcomes Research Act of 2009 Alan Goldberg 0 6/22/2009 12:11 PM Medicare IDE Trial requirements? Lynne Rasmussen 1 6/18/2009 2:04 PM Life Sciences expertise and AHLA's ADR Service Peter Leibold 0 6/5/2009 3:57 PM [No rule yet for GINA 2008 under Section 105, but tomorrow is May 21, 2009 -- nothing in today's Federal Register.] Alan Goldberg 0 5/20/2009 6:40 AM New IOM documents for clinical trial agreements and material transfer agreements Adam Rifkind 0 5/15/2009 8:35 AM CMS releases IPPS Proposed Rule Jayson Slotnik 0 5/1/2009 4:53 PM Speak at the Life Sciences Law Institute in October and Come to the Annual Meeting in June Peter Leibold 0 4/29/2009 5:27 PM Speak at the Life Sciences Law Institute and Come to the Annual Meeting Peter Leibold 0 4/28/2009 1:37 PM The promise of cheap genome sequencing Alan Goldberg 0 4/19/2009 10:05 AM GINA 2008 Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards Alan Goldberg 0 4/9/2009 3:09 PM BNA article on implications of Pres Obama stem cell executive order Wendy Krasner 0 4/3/2009 12:23 PM Medicaid Coverage for Routine Costs in Clinical Trials Susan Tuite 2 4/1/2009 4:43 PM Clinical Trial Agreements: Warranty Disclaimers and Liability Limitations Ryan Johnson 2 3/26/2009 8:18 AM Health Care Information Technology Vendors' "Hold Harmless" Clause Alan Goldberg 0 3/25/2009 6:40 AM Human Genome Sciences' Future Rides on Success of New Treatments Alan Goldberg 0 3/23/2009 6:32 AM AHLA Medicare Medicaid Seminar Baltimore March 24-27, 2009 http://www.pagegangster.com/p/kZqKU/ Alan Goldberg 0 3/20/2009 8:45 AM FDA Commissioner and Deputy Commissioner News Ryan Johnson 0 3/11/2009 5:44 PM Medical Device Safety Act Peter Leibold 0 3/5/2009 5:51 PM OHRP Proposed Rule Rachel Nosowsky 0 3/5/2009 7:56 AM WYETH, PETITIONER v. DIANA LEVINE Alan Goldberg 0 3/5/2009 7:06 AM GINA 2008 & Are Governments Covered Alan Goldberg 0 3/4/2009 3:33 PM Sec. 1180. Application of HIPPA [sic]regulations to genetic information Alan Goldberg 0 3/3/2009 1:29 AM Additional Member Comments Added to Interview with Gerald Masoudi, Outgoing Chief Counsel, FDA Jayson Slotnik 0 3/2/2009 8:39 AM CMS has posted the revised Draft 2010 Call Letter for Part C and Part D Wendy Krasner 0 2/24/2009 8:07 AM GINA 2008 HIPAA Genetic information shall be treated as health information described in section 1171(4)(B) Alan Goldberg 0 2/24/2009 1:36 AM ARRA 09 Text via Conference Report for HR1 Alan Goldberg 0 2/18/2009 4:37 AM From AHLA Technology - status update and some good news Thad Lurie 0 2/17/2009 2:56 PM HITECH provisions excerpted from Stimulus/Spending bill Alan Goldberg 0 2/14/2009 8:03 AM Privacy Provisions of Soon to Be New Law; Stimulus/Spending Bill; HIPAA & More Alan Goldberg 0 2/14/2009 7:03 AM NIH Gets Ten Billion More Dollars Alan Goldberg 0 2/14/2009 5:53 AM Interview with Gerald Masoudi, Outgoing Chief Counsel, FDA Jayson Slotnik 0 2/13/2009 5:09 PM Text of Tax and Healthcare provisions for stimulus package Jayson Slotnik 0 2/12/2009 7:14 PM New List Policies and Procedures - *PLEASE READ* Thad Lurie 0 2/11/2009 1:22 PM IOM Report on HIPAA Rachel Nosowsky 0 2/5/2009 5:53 PM Interview with Gerald Masoudi, Outgoing Chief Counsel of the FDA Jayson Slotnik 0 2/5/2009 5:16 PM

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