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Results: 1-10 of 476

FDA proposed rule would eliminate certain drug pedigree requirements

  • Reed Smith LLP
  • -
  • USA
  • -
  • July 18 2011

On July 14, 2011, the Food and Drug Administration published a proposed rule to remove a section of the Prescription Drug Marketing Act regulations to permit wholesale distributors to document the chain of custody (also known as the "pedigree") of prescription drug products only back to the last "authorized distributor" instead of all the way back to the manufacturer

In Iqbal v. Ashcroft, the United States Supreme Court rejects truthiness as the pleading standard under Rule 8

  • Reed Smith LLP
  • -
  • USA
  • -
  • June 10 2009

The American Dialect Society named "truthiness" as the word of the year for 2005 and Merriam-Webster followed suit in 2006

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

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