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Deja Food: FDA Issues Draft Guidance to Protect Food Against Intentional Adulteration
  • Morgan Lewis & Bockius LLP
  • USA
  • June 28 2018

The FDA on June 20 issued the first four chapters of a nine-chapter draft guidance titled “Mitigation Strategies to Protect Food Against Intentional


FDA Issues Draft Guidance Documents on Shared System REMS
  • Morgan Lewis & Bockius LLP
  • USA
  • June 15 2018

The documents issued by the US Food and Drug Administration on shared system risk evaluation and mitigation strategies signal the FDA’s willingness to


Life Sciences International Review Q2 2018
  • Morgan Lewis & Bockius LLP
  • USA, United Kingdom, European Union, France
  • June 6 2018

The most-significant recent development is the entry into force on 25 May of the EU General Data Protection Regulation. This new legislation will have


Federal Right to Try Bill Becomes Law in Wake of State Laws
  • Morgan Lewis & Bockius LLP
  • USA
  • May 30 2018

The federal bill was signed into law on May 30 by the president, and will present new opportunities and challenges to clinical trial sponsors and


FDA Issues Guidance on Federal Menu Labeling Rule
  • Morgan Lewis & Bockius LLP
  • USA
  • May 8 2018

Three years after FDA’s final rule on menu labeling was published, the compliance date for the rule finally went into effect on May 7. The federal


USDA Releases Long-Awaited Bioengineered Labeling Disclosure Rule
  • Morgan Lewis & Bockius LLP
  • USA
  • May 4 2018

The US Department of Agriculture, through its Agricultural Marketing Service, released its highly anticipated rule proposing a nationwide labeling


No Such Thing as Simple Food Labeling: Changes Ahead in 2018
  • Morgan Lewis & Bockius LLP
  • USA
  • April 9 2018

Significant statutory and regulatory changes are on the horizon this year in the world of food labeling as regulators and lawmakers introduce rules


Healthcare: What’s in the 2018 Omnibus Appropriations Law?
  • Morgan Lewis & Bockius LLP
  • USA
  • March 30 2018

The recently passed omnibus appropriations bill includes extensive funding, often at higher amounts than in fiscal year 2017, for many US healthcare


FDA Delays eMDR System Adverse Event Codes Update
  • Morgan Lewis & Bockius LLP
  • USA
  • March 30 2018

The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5


FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices
  • Morgan Lewis & Bockius LLP
  • USA
  • February 27 2018

The US Food and Drug Administration's new requirements for sponsors to follow Good Clinical Practices (GCPs) for ex-US device clinical trials will