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Failure to Report Claimed Allowed, But Plaintiff Shouldn’t Feel Bullish
  • Dechert LLP
  • USA
  • July 24 2018

We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn

Consumer awareness in the FMCG sector
  • George Etomi & Partners
  • Nigeria
  • April 2 2018

Fast-moving consumer goods (FMCG) are products that are sold quickly and at relatively low cost. Examples include non-durable goods such as packaged

Biotech Policy Takes Shape: Rural Task Force Encourages Innovation and Regulatory Coordination
  • Arent Fox LLP
  • USA
  • January 22 2018

On January 8, 2018, the US Secretary of Agriculture, on behalf of the Interagency Task Force on Agriculture and Rural Prosperity, issued its

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