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Results: 1-10 of 212

Another State Bans Routine Antibiotic Use in Food-Producing Animals
  • Keller and Heckman LLP
  • USA
  • June 5 2017

As previously covered on this blog here and here, for years, FDA, USDA, and various industry stakeholders have sought to tackle public health concerns


FDA Invites Stakeholder Input in Preparation for ICCR-10 Meeting
  • Shook Hardy & Bacon LLP
  • USA
  • April 29 2016

The U.S. Food and Drug Administration (FDA) has announced a public meeting slated for June 15, 2016, in Bethesda, Maryland, to collect public input


Fed. Cir. Confirms 271(e)(1) safe harbor applies to post-approval development of clinical data for citizen petition and supplemental new drug application
  • Brinks Gilson & Lione
  • USA
  • May 22 2015

On appeal from the District of Maryland, the Federal Circuit held in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., that the §


FDA Science Forum to target role of scientific research in regulatory decision making
  • Shook Hardy & Bacon LLP
  • USA
  • April 10 2015

The U.S. Food and Drug Administration (FDA) will host a public workshop titled "FDA Science Forum 2015" on May 27-28 in Silver Spring, Maryland. The


FDA to solicit public input on supplemental proposed rules under FSMA
  • Shook Hardy & Bacon LLP
  • USA
  • October 24 2014

The U.S. Food and Drug Administration (FDA) has scheduled a November 13, 2014, public meeting in College Park, Maryland, to solicit stakeholder


Breaking news Maryland High Court holds FDA regulatory status cannot support informed consent claim
  • Reed Smith LLP
  • USA
  • April 25 2014

We've blogged several times about the nearly unanimously accepted proposition that FDA regulatory status - that is, the bare fact that a drug or


Hearing on OTC drug review scheduled
  • Shook Hardy & Bacon LLP
  • USA
  • February 27 2014

The U.S. Food and Drug Administration (FDA) will conduct a public hearing on March 25-26, 2014, in silver spring, Maryland, "to obtain information


Hatch-Waxman safe harbor expansion continues
  • Fish & Richardson PC
  • USA
  • February 12 2014

In a January 28 decision, the District Court of Maryland dismissed a patent infringement suit for failure to state a claim because the accused


FDA to discuss protecting food against intentional adulteration
  • Shook Hardy & Bacon LLP
  • USA
  • January 10 2014

The U.S. Food and Drug Administration (FDA) has announced a public meeting on February 20, 2014, in College Park, Maryland, to "discuss its proposed


Maryland device manufacturer licensing form over substance
  • Porzio Bromberg & Newman PC
  • USA
  • February 22 2012

There are certain fundamental truths within state regulatory frameworks