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Results: 1-10 of 419

Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals

  • Reed Smith LLP
  • -
  • USA
  • -
  • February 12 2010

FDA recently issued a revision of an International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document, M3(R2), that was published in 1997 and is intended to harmonize and recommend international standards for non-clinical safety studies conducted to support human clinical trials of a given scope and duration, andor to be relied upon for marketing authorization for pharmaceuticals

Pennsylvania courts struggle with insurance coverage for defective product claims

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 28 2013

In 2012, Judge Wettick of the Allegheny County Court of Common Pleas issued two decisions that have the potential to significantly limit the

Aredia-Zometa court rejects PA heeding presumption, finds black box preempted, and garbles some other issues

  • Reed Smith LLP
  • -
  • USA
  • -
  • October 2 2013

In the index to this blog, we list 39 posts about the Aredia-Zometa litigation. After today it will be 40. And counting. That might actually be

A preemption win for an innovator drug

  • Reed Smith LLP
  • -
  • USA
  • -
  • July 10 2013

Since the unfortunate decision in Wyeth v. Levine, 555 U.S. 555 (2009), successful applications of preemption against warning claims asserted in

Sorry, your baby can't read

  • Reed Smith LLP
  • -
  • USA
  • -
  • September 12 2012

Just before Labor Day, the Federal Trade Commission (FTC) filed false advertising charges against the marketers of “Your Baby Can Read!” The program, widely promoted via infomercials and the Internet, purports to use videos, flash cards and pop-up books to teach babies as young as 3 months old how to read

FDA guidance on enforcement of regulations restricting sale and distribution of cigarettes & smokeless tobacco

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 13 2010

FDA has issued a guidance document entitled "Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco."

FDA updates TSE and Mad Cow Disease guidance for medical devices

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 27 2014

While many of us may think of medical devices as complex combinations of metals, plastics, and electronics, many medical devices also contain

Seventh Circuit holds that voluntary product refund programs can defeat class certification on adequacy grounds under Rule 23(a)(4)

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 23 2012

Previously, we advised of a federal district court decision that endorsed a creative option for defeating class certificationthe defendant’s implementation of a product refund and replacement program providing a comparable remedy to what the putative class might recover in court

Our favorites - the best prescription drugmedical device decisions of 2012

  • Reed Smith LLP
  • -
  • USA
  • -
  • December 28 2012

We hope all our readers had an excellent holiday-of-your-choice. We did, and we're back just in time for our favorite (and nearly last) post of the

Celebrating free speech on the Fourth of July

  • Reed Smith LLP
  • -
  • USA
  • -
  • July 4 2013

The Fourth of July is the time to celebrate everything American - baseball, apple pie, almost anything that's red, white and blue (ironically so are