We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results:1-10 of 23

France Simplifies Local Medical Device Regulations and Sets Precedent for Other Member States
  • Jones Day
  • European Union, France
  • May 23 2018

On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016


New French Decree Clarifies the Scope of Biomedical Research, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
  • Jones Day
  • France
  • June 29 2017

French Decree n 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to


Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
  • Jones Day
  • USA
  • June 4 2017

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget


FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
  • Jones Day
  • USA
  • June 4 2017

On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment


Guidance for European MA Holders to Prepare for Brexit, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
  • Jones Day
  • United Kingdom, European Union
  • June 4 2017

The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United


New York Attorney General Announces Settlements with Three Mobile Health Application Developers
  • Jones Day
  • USA
  • May 12 2017

New York has made a mark on the regulatory and enforcement landscape for mobile health applications ("mobile health app") with the New York Attorney


UK's Regulator Announces Its Top Priorities in the Lead Up to Brexit
  • Jones Day
  • United Kingdom, European Union
  • May 12 2017

The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's pharmaceutical and medical devices regulator, has recently released its


Pharmaceutical & Medical Device Regulatory Update, Vol. IV, Issue 1
  • Jones Day
  • USA
  • April 12 2017

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products


Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 7
  • Jones Day
  • USA
  • September 21 2016

On November 9 and 10, 2016, FDA will host a public hearing to obtain feedback on the Agency's regulation of communications by manufacturers, packers


Pharmaceutical & medical device regulatory update, Vol. II, Issue 18
  • Jones Day
  • USA
  • November 20 2015

On November 17, 2015, Dr. Robert Califf testified in front of the Senate Committee on Health, Education, Labor, and Pensions as President Obama's