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Results: 11-20 of 11,439

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


Sandoz v Amgen: An update
  • Bristows
  • USA
  • January 9 2018

In our most recent publication, the Bristows' Biotech Review (Page 3), we reported on the US Supreme Court decision which, at the time, was the latest


Amgen Moves to Dismiss Genentech’s Misrepresentation Claim
  • Morgan Lewis
  • USA
  • January 9 2018

Amgen paints a different picture as to the bad actor during the parties’ negotiations pursuant to the Biologics Price Competition and Innovation Act


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


Attorney General Sessions Memo Frees Federal Prosecutors to Pursue Marijuana Cases - What Does It Mean for Broadcast Advertisements?
  • Wilkinson Barker Knauer LLP
  • USA
  • January 5 2018

Yesterday, Attorney General Jeff Sessions issued a one-page memo (here) advising Federal prosecutors to use their discretion in pursuing marijuana


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


Standing Questioned Before the Federal Circuit in Momenta Pharms. v. Bristol-Myers Squibb Co.
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 5 2018

On December 5, 2017, the Federal Circuit held oral argument in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, 17-1694. The case comes


FSMA Update: FDA Issues Guidance on Enforcement Discretion Related to FSMA Provisions
  • Keller and Heckman LLP
  • USA
  • January 5 2018

Today, the FDA published guidance outlining key areas where it intends to exercise enforcement discretion in four of the rules that implement aspects