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Results:1-10 of 143

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

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

There are certain fundamental truths within state regulatory frameworks.

Del Monte dismisses lawsuit seeking to lift cantaloupe import restrictions
  • Shook Hardy & Bacon LLP
  • USA
  • September 30 2011

Del Monte Fresh Produce N.A. has filed a notice of dismissal in a Maryland federal court after the Food and Drug Administration (FDA) agreed to lift the import alert it imposed on cantaloupes from Guatemala that had purportedly been linked to a Salmonella outbreak.

Maryland Court of Appeals clarifies scope of wrongful discharge tort
  • Whiteford Taylor & Preston LLP
  • USA
  • September 26 2011

Maryland courts have long recognized a common law right of action for employees who allege that they were terminated in violation of a public policy.

Maryland board of pharmacy stages a limited retreat from its definition of “manufacturer” for licensing purposes
  • Porzio Bromberg & Newman PC
  • USA
  • July 7 2011

Any manufacturer or private label distributor that utilizes a contract manufacturing organization (CMO) can share horror stories about the year-end renewal of the Maryland distribution license.

In-house counsel acquitted of obstruction charges arising from dealings with federal agency
  • Kelley Drye & Warren LLP
  • USA
  • May 12 2011

On May 9, a federal judge in Baltimore acquitted a former associate general counsel of GlaxoSmithKline PLC ("GSK") of all charges of obstructing justice and lying to federal authorities in an investigation into the off-label marketing of the anti-depressant drug Wellbutrin.