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Results: 1-10 of 6,647

FDA Proposes to Delay Off-Label “Intended Use” Rule
  • Reed Smith LLP
  • USA
  • January 16 2018

Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but


3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing
  • Morrison & Foerster LLP
  • USA
  • January 16 2018

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The


OIG Report Highlights Impact of Improper Drug Classification
  • Arent Fox LLP
  • USA
  • January 12 2018

In late December 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released the findings of a report


Food, Dietary Supplement & Cosmetics Update Vol. V, Issue 1
  • Jones Day
  • USA, European Union
  • January 12 2018

On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce certain provisions


FDA to step up enforcement of homeopathic medicine
  • Thompson Coburn LLP
  • USA
  • January 11 2018

Homeopathic medicine has long occupied a niche in American culture. Since 1988, with the issuance of the Compliance Policy Guide, 400.400


FDA Extends Enforcement Discretion on Certain FSMA Provisions
  • Keller and Heckman LLP
  • USA
  • January 9 2018

On January 5, 2018, FDA published a Guidance for Industry, "Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and


FDA Announces Enforcement Discretion for Food-Contact Substance Compliance with FSVP
  • Keller and Heckman LLP
  • USA
  • January 8 2018

The U.S. Food and Drug Administration (FDA) announced January 4, 2018, that it intends to exercise enforcement discretion with respect to requiring


FDA Announces Enforcement Discretion for Certain FSMA Provisions
  • Hogan Lovells
  • USA
  • January 8 2018

On January 4, 2018, the Food and Drug Administration (FDA) announced through Guidance that it does not intend to enforce particular provisions of the


New Hampshire Bill Would Requires Ingredient Labels and Ban Certain Ingredients for E-Liquids
  • Troutman Sanders LLP
  • USA
  • January 5 2018

A bill was introduced in the New Hampshire legislature on January 3, 2018 regarding the regulation of e-liquids. The bill, NH18-H.1812, specifically


The Crackdown Continues: FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns
  • Hogan Lovells
  • USA
  • January 5 2018

Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcellan adipose tissue derived stem cell