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EU - US mutual recognition of GMP inspections: agreement published
  • Hogan Lovells
  • European Union, USA
  • March 20 2017

On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal


340B Program: Ceiling Price and CMP Final Rule Delayed Until May 22--Comments Requested on Possible Further Delay
  • Hogan Lovells
  • USA
  • March 20 2017

On 20 March 2017, the Health Resources and Services Administration (HRSA) published an Interim Final Rule (IFR) delaying the effective date of the


CFIUS Reform Turns to Food Security
  • Hogan Lovells
  • USA
  • March 20 2017

Congressional efforts to reform the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee that


Guide to Recent Biosimilar Activity by FDA and in the Supreme Court
  • Hogan Lovells
  • USA
  • March 16 2017

The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final


Republicans release much anticipated ACA "repeal and replace" bill, but will it fly under the Byrd rule?
  • Hogan Lovells
  • USA
  • March 7 2017

On 6 March 2017, House Republicans in the Committee on Ways and Means and the Committee on Energy and Commerce introduced the American Health Care


U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to Continue Shifting Inspections and Enforcement Focus to Asia
  • Hogan Lovells
  • European Union, USA
  • March 2 2017

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of


What’s in store for the Affordable Care Act and drug pricing policy under the Trump administration?
  • Hogan Lovells
  • USA
  • February 27 2017

The Trump administration has been vocal in its criticism of the Affordable Care Act (ACA), and already has worked with the Republican-controlled


US bribery and corruption outlook
  • Hogan Lovells
  • USA
  • February 20 2017

Nations across the globe increasingly focus on preventing bribery and corruption and are coordinating their efforts to do so more than ever before


Trump Administration Issues Proposed Health Insurance Market Stabilization Rule: Will It Be Enough to Stabilize Exchange Participation and Premium Rates?
  • Hogan Lovells
  • USA
  • February 16 2017

On 15 February 2017, the Centers for Medicare & Medicaid Services (CMS) took a step toward addressing concerns about the stability of the individual


False Claims Act Alert: Fourth Circuit Punts on Sampling and Extrapolation
  • Hogan Lovells
  • USA
  • February 15 2017

Yesterday, the Fourth Circuit Court of Appeals ruled in the interlocutory appeal in United States ex rel. Michaels v. Agape Senior Community, Inc