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FDA Begins Reorganization that Will Affect How it Regulates Medical Technology
  • Hogan Lovells
  • USA
  • June 1 2017

The U.S. Food and Drug Administration (FDA) has undertaken significant reorganization efforts this year that affect the way it regulates medical


Capitol Hill Healthcare Update
  • Baker & Hostetler LLP
  • USA
  • April 7 2017

House Republicans of all ideological stripes say they are committed to rekindling interest in the American Health


The ‘Searching for and Cutting Regulations that are Unnecessarily Burdensome Act’ Passes the House
  • Cooley LLP
  • USA
  • March 5 2017

On March 1st, the U.S. House of Representatives (House) passed the Searching for and Cutting Regulations that are Unnecessarily Burdensome Act (SCRUB


Congress Wants to Reform Agency Rulemaking: Refinements or Tectonic Shifts?
  • Epstein Becker Green
  • USA
  • January 25 2017

Congress is currently considering two bills that would dramatically alter the ways in which all federal agencies develop and publish rules. If


Intellectual Property Linkage: Connecting IP Offices with Regulators
  • Tilleke & Gibbins
  • Thailand
  • November 30 2016

Intellectual property (IP) linkage refers to connecting an IP office, through open communication lines and complementary processes, to other


FDA finalizes rule on citizen petitions delaying generic approvals; declines PhRMA requests
  • Loeb & Loeb LLP
  • USA
  • November 29 2016

He final rule makes clear that the FDA will not delay the approval of pending ANDA, 505(b)(2) or 351(k) applications because of citizen petitions


Washington Healthcare Update - November 21, 2016
  • McGuireWoods LLP
  • USA
  • November 21 2016

On Nov. 17, the House of Representatives passed a bill that would make it easier to kill so-called midnight rules issued during a President’s final


Let’s Get Real: Meredith Manning Urges FDA to Allow Greater Communication of Real World Data Within Its Current Regulatory Framework
  • Hogan Lovells
  • USA
  • November 7 2016

On October 26, 2016, Hogan Lovells partner Meredith Manning submitted a comment to the U.S. Food and Drug Administration (FDA) urging the agency to


Mylan Agrees to $465 Million Settlement with DOJ Over EpiPen Medicaid Drug Rebate Reporting Classification
  • Arent Fox LLP
  • USA
  • October 11 2016

Mylan recently announced a $465 million settlement with the US Department of Justice and other government agencies regarding the company's covered


HHS Increases Civil Monetary Penalties and 299 Other Fines
  • Epstein Becker Green
  • USA
  • September 30 2016

Health care providers, life sciences companies and other entities subject to regulation by the Food and Drug Administration (“FDA”) or the Centers