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Search Results (7184) Documents on health care Show: results per page Sort by:  | FDA Issues Draft Guidance on Evaluating Substantial Equivalence in 510(k) Premarket Notifications
Krista Hessler Carver, Scott D. Danzis, Ellen J. Flannery, Christina Kuhn; Covington & Burling LLP;
Legal Alert/Article February 13, 2012, previously published on February 7, 2012 On December 28, 2011, the Food and Drug Administration (FDA) issued a draft guidance document intended to explain and clarify each of the critical decision points in the Center for Devices and Radiological Health’s (“CDRH”) decision-making process for determining substantial...
| | CMS Issues Proposed Rule to Implement Drug Pricing and Rebate Provisions of the Affordable Care Act
Shelton Abramson, Stefanie A. Doebler, Demetrios L. Kouzoukas, Anna D. Kraus; Covington & Burling LLP;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 On February 2, 2012, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would implement sections of the Affordable Care Act (ACA) and make other revisions to the Medicaid Drug Rebate Program (MDRP). The proposed rule addresses a broad range of issues related to...
|  | HHS-DOL-Treasury Summary of Benefits and Coverage and Uniform Glossary Final Rule | Summary
Thomas Barker, Maia M. Larsson; Foley Hoag LLP;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 Section 2715 of the Public Health Service Act (PHS Act), which was enacted as part of the Patient Protection and Affordable Care Act (also referred to as PPACA, the Affordable Care Act, or the ACA), requires health insurers and group health plans offering health care coverage to enrollees and...
| | Prescription Medications: A “Catch-22”
Frank B. Harty; Nyemaster, Goode, West, Hansell & O'Brien A Professional Corporation;
Legal Alert/Article February 13, 2012, previously published on February 9, 2012 In the wake of the Loren Bishop trial in the Polk County District Court, the public is acutely aware of the risks posed by operating machinery while under the influence of pain killers. Common sense dictates that any medication that carries with it a warning that it “may cause...
| | FDA Releases Long-Awaited Draft Guidances on Biosimilar Product Development
Barbara A. Fiacco, James M. Flaherty, Paul T. Kim, Donald R. Ware; Foley Hoag LLP;
Legal Alert/Article February 13, 2012, previously published on February 9, 2012 Today, the U.S. Food and Drug Administration (FDA) released three draft guidance documents designed to assist industry in developing biosimilars. Biosimilar products are biological products shown to be highly similar (biosimilar) to biological products previously approved by FDA (known as...
| | Recent Labor Law News in Lebanon
Aref El-Aref; El-Aref International Law Office;
Legal Alert/Article February 13, 2012 Minimum Wages of Employees Fixed by Decree No. 7426/2012
| | FDA’s Draft Guidance on Scientific Considerations in Demonstrating Biosimilarity
Barbara A. Fiacco, James M. Flaherty, Paul T. Kim, Donald R. Ware; Foley Hoag LLP;
Legal Alert/Article February 13, 2012, previously published on February 10, 2012 Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI...
| | University Fined $115,000 for Discriminatory I-9 Practices
Melissa A. Dearing; Fowler White Boggs P.A.;
Legal Alert/Article February 10, 2012, previously published on January 2012 Last December, the Department of Justice (DOJ) filed suit against The University of California San Diego Medical Center (UCSD) for an alleged pattern or practice of requesting excessive I-9 documentation. UCSD has now agreed to pay a civil penalty of $115,000 to settle the lawsuit. The University...
| | Employer Meetings, Election Site The Next Targets Of NLRB?
Mark Theodore; Proskauer Rose LLP;
Legal Alert/Article February 10, 2012, previously published on February 9, 2012 It's been a quiet few weeks for the NLRB. Since January 1, the NLRB has issued only a small number of decisions, none of which appear to be noteworthy. There are, of course, many developments that are in process. For example, we still do not know the full effect of the NLRB's decision in...
| | Third Circuit Reaffirms Viability of Deepening Insolvency Claim
Nancy Chu; Jones Day;
Legal Alert/Article February 10, 2012, previously published on January/February 2012 In Official Committee of Unsecured Creditors v. Baldwin (In re Lemington Home for the Aged), 659 F.3d 282 (3d Cir. 2011), the Third Circuit Court of Appeals held, among other things, that the “deepening insolvency” cause of action, which the Third Circuit previously recognized in...
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