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Results:1-10 of 206

FDA Finalizes Program for Medical Device Reporting in Summary Form for Certain Manufacturers
  • Morgan Lewis
  • USA
  • October 1 2018

The US Food and Drug Administration (FDA) issued an order in the Federal Register on August 17 announcing a new "Voluntary Malfunction Summary


Impending Tariffs on China to Impact Manufacturers of Dietary Supplements, OTC Drugs, Cosmetics
  • Morgan Lewis
  • USA, China
  • September 19 2018

Newly approved tariffs would impose 10 to eventual 25 tariffs on hundreds of chemical ingredients imported from China used for many FDA-regulated


FDA: Probiotic Products Can Use CFUs on Supplement Facts Panel
  • Morgan Lewis
  • USA
  • September 10 2018

In a draft guidance document, the US Food and Drug Administration stated that in certain cases, it will allow probiotic products to use colony-forming


FDA Releases Policy on Risk-Based Inspections
  • Morgan Lewis
  • USA
  • September 10 2018

The policy sheds light on risk factors but does not provide inspection predictability. Manufacturers should therefore continue to ensure inspection


Takeaways from FDA ‘Steak-holder’ Meeting on Cell-Cultured Foods
  • Morgan Lewis
  • USA
  • July 13 2018

The Food and Drug Administration (FDA) held a public meeting July 12 on “Foods Produced Using Animal Cell Culture Technology” to give the public an


Deja Food: FDA Issues Draft Guidance to Protect Food Against Intentional Adulteration
  • Morgan Lewis
  • 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The FDA on June 20 issued the first four chapters of a nine-chapter draft guidance titled “Mitigation Strategies to Protect Food Against Intentional


FDA Issues Draft Guidance Documents on Shared System REMS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
  • 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
  • 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
  • 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
  • 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