Your search for Articles on pharmaceuticals, found 454 article(s).
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| 1 | OIG Reports on FDA Generic Drug Review Process Frederick R. Ball; Duane Morris LLP; July 8, 2008, previously published on June 23, 2008 On June 13, 2008, the Office of Inspector General for the U.S. Department of Health and Human Services (the "OIG") released its report entitled "The Food and Drug Administration's Generic Drug Review Process." |
| 2 | Regulatory Reminder: Stark Requires Individual Contracts for Physician Independent Contractors Edgar C. Morrison; Jackson Walker L.L.P.; June 27, 2008, previously published on June 12, 2008 Buried in a flurry of CMS rulemaking in 2007 was an amendment to the Stark regulations affecting medical groups that hire independent contractor physicians to provide services at their facilities. |
| 3 | FDA Issues Proposed Rule on Pregnancy and Lactation Labeling Christina M. Markus, Beverly Lorell; King & Spalding LLP; June 26, 2008, previously published on June 10, 2008 On May 29th, FDA issued a proposed rule that would require major revisions of both the format and content of prescription drug and biological labeling with respect to pregnancy and lactation. The FDA states that the revised labeling is intended to provide more complete information for physicians... |
| 4 | CMS Names New Compendium to Approved List for Off Label Coverage Determinations Laura E. Loeb, Mark Smith; King & Spalding LLP; June 26, 2008, previously published on June 9, 2008 On June 5, 2008, CMS added the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium to its list of approved sources for making off-label coverage determinations for Part B anti-cancer drugs. |
| 5 | New Jersey Supreme Court Restricts Claims for 'Medical Monitoring' John F. Brenner; Pepper Hamilton LLP; June 26, 2008, previously published on June 10, 2008 On June 4, 2008, the New Jersey Supreme Court issued its opinion in Sinclair v. Merck & Co., Inc., in which it refused to recognize claims for medical monitoring by persons who claimed no current, "manifest" injury. |
| 6 | New Jersey Intermediate Appellate Court Splits Pre-emption Rulings in Vioxx Case Deborah Moreland Russell; McGuireWoods LLP; June 24, 2008, previously published on June 9, 2008 On May 29, 2008, New Jersey's intermediate appellate court stepped into the pre-emption fray and decided that state law failure-to-warn claims challenging the adequacy of prescription drug labeling are not pre-empted under the Food, Drug and Cosmetic Act ("FDCA") whereas the... |
| 7 | Merck Wins Partial Victory in Vioxx Litigation Michael J. Slocum, Sheila A. Woolson; Epstein Becker & Green, P.C.; June 24, 2008, previously published on June 2008 The New Jersey Appellate Division has reversed a jury award of punitive damages against pharmaceutical manufacturer Merck & Co., Inc., for its marketing of the pain reliever Vioxx, holding that federal laws partially preempt the New Jersey Product Liability Act (PLA). McDarby v. Merck &... |
| 8 | Quality of Care: Update on DHHS Quality Initiatives and Value-Based Purchasing Rebekah A.Z. Monson; Pepper Hamilton LLP; June 21, 2008, previously published on May 2008 While the mainstream media has recently paid increased attention to the quality of health care, the federal government has actually been ahead of the story for several years. The Department of Health and Human Services (DHHS), under the direction of Congress, is continuing to propose or implement a... |
| 9 | Legal Implications of Physician Consultants John W. Jones; Pepper Hamilton LLP; June 21, 2008, previously published by Physician's News Digest on May 2008 Increased federal investigation into alleged inappropriate arrangements between the pharmaceutical and medical device industries and physicians has led to significant scrutiny over many, even legitimate, consulting, design development and license agreements and other services arrangements. |
| 10 | Post-Market Surveillance: FDA's "Sentinel Initiative" and Related CMS Rulemaking Catherine A. Durkin, Areta L. Kupchyk; Reed Smith LLP; June 21, 2008, previously published on May 2008 On May 22, 2008, the Food and Drug Administration ("FDA") announced plans for what it is calling the "Sentinel System"--a new, national electronic health information surveillance system to track the performance and safety of medical products once they are on the market. |
