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Results: 1-10 of 3,711

A One-Two Punch Case With An Off-Label Twist
  • Reed Smith LLP
  • USA
  • July 22 2016

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of


Something Went Right In Brazil
  • Reed Smith LLP
  • USA
  • July 19 2016

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment a lot of things have gone wrong in Brazil lately. But we're


Biosimilar applicants must provide notice of commercial marketing
  • Fanelli Haag
  • USA
  • July 19 2016

In a recent case involving Apotex’s proposed biosimilar product to Amgen’s Neulasta (pegfilgrastim). Amgen sought a preliminary injunction to


Second-Hand Smoke: How Colorado’s Neighbors Are Fighting Amendment 64
  • Seyfarth Shaw LLP
  • USA
  • July 19 2016

Not everybody has been high on life since Colorado passed Amendment 64 on November 6, 2012, which legalized the sale and distribution of marijuana in


Fixed-Combination Drug Products Eligible for Five-Year Exclusivity
  • McDermott Will & Emery
  • USA
  • July 19 2016

Addressing whether the US Food and Drug Administration's (FDA) denial of Ferring Pharmaceutical's application for marketing exclusivity was arbitrary


Fraudulent Joinder & Bad Faith - Explaining Another Removal Muddle
  • Reed Smith LLP
  • USA
  • July 18 2016

Here's some more inside baseball on grounds for removing cases from state to federal court. In brief, the issue is this: does the "bad faith"


Not so Wonderful: What the food industry can learn from Pom’s faulty health claims
  • Thompson Coburn LLP
  • USA
  • July 18 2016

In today's health-conscious environment, consumers are more attuned to the food, beverages, and dietary supplements they use. A product's possible


FDA Argues Time Frame for Perchlorate Decision is Reasonable
  • Shook Hardy & Bacon LLP
  • USA
  • July 15 2016

The U.S. Food and Drug Administration (FDA) has filed an opposition to a petition for a writ of mandamus seeking a response to several consumer


California Federal Court Rejects Plaintiff’s Class Certification Request
  • Shook Hardy & Bacon LLP
  • USA
  • July 15 2016

A California federal court has denied a class certification and consolidation request in a lawsuit alleging Pharmacare US, Inc.'s IntenseX Sexual


FDA Denies Three Petitions on Biosimilar Labeling: Refers Petitioners to Guidance Process
  • Hogan Lovells
  • USA
  • July 15 2016

The U.S. Food and Drug Administration denied three pending petitions regarding biosimilar labeling without substantively addressing most of the