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Results:1-10 of 5,727

Expanded Scope of the Physician Sunshine Act Is on the Horizon
  • Arent Fox LLP
  • USA
  • October 16 2018

Existing law already requires drug manufacturers and medical device companies to report certain payments and transfers of value provided to


New Draft Guidance on Adaptive Designs for Clinical Trials
  • Epstein Becker Green
  • USA
  • October 16 2018

Two draft guidances issued together late last month seek to increase both clinical trial efficiency and the amount of information that is available


HHS Secretary Azar Announces DTC Drug Price Transparency Proposal, Foreshadows Additional Regulatory Action to Address Drug Prices
  • Sidley Austin LLP
  • USA
  • October 16 2018

On October 15, 2018, Secretary of Health and Human Services (HHS) Alex Azar delivered remarks at a National Academy of Medicine event in which he


Highlights of the USMCA
  • Miller Thomson LLP
  • USA, Mexico, Canada
  • October 11 2018

On September 30, 2018, the United States, Mexico and Canada reached a new trade agreement, the United States-Mexico-Canada Agreement (“USMCA”). This


A New SEC Focus On Short Activism? Activist Hedge Fund Lemelson Capital Charged with Unlawful Short Attack
  • Vinson & Elkins LLP
  • USA
  • October 8 2018

On September 12, 2018, the Securities and Exchange Commission charged hedge fund, Lemelson Capital and its adviser, Gregory Lemelson (together with


FDA schedules public hearing on solutions to drug shortages
  • Hogan Lovells
  • USA
  • October 8 2018

FDA schedules public hearing on solutions to drug shortages October 08, 2018 The U.S. Food and Drug Administration (FDA) has announced it will hold a


FDA Draft Guidance on Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 8 2018

On September 28, 2018, FDA issued draft guidance on contents of a complete submission for threshold analyses and human factors (HF) submissions to


Friday Enforcement Wrap: Physician Association Settles for $270 Million & More Top Headlines
  • Arent Fox LLP
  • USA
  • October 5 2018

DaVita Medical Holdings LLC entered into a $270 million settlement agreement with the Justice Department to resolve False Claims Act claims


FDA Final Guidance on Content and Format of ANDA Applications
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 4 2018

On September 24, 2018, FDA issued final guidance on ANDA Submissions - Content and Format. The guidance outlines recommendations for the information


Employment Drug Testing Policies: Up in Smoke?
  • Breazeale Sachse & Wilson LLP
  • USA
  • September 18 2018

As state laws on marijuana use continueto change, employers are left wondering how such laws may affect their workplace drug-testing policies. While