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FDA Generic Labeling Proposal - Six, Two, and Even, Over and Out
  • Reed Smith LLP
  • USA
  • December 17 2018

We opposed the FDA’s ill-advised 2013 proposal to revamp the process for changing generic drug labeling from the outset. We had legal objections -


FDA Withdraws Proposed Generic Drug Labeling Rule
  • Duane Morris LLP
  • USA
  • December 17 2018

The U.S. Food and Drug Administration recently announced it will withdraw a proposed rule that would have required generic drug manufacturers to


CMS considers linking Medicare drug payment rates to international prices
  • Hogan Lovells
  • USA
  • October 30 2018

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) describing a potential


Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”
  • Seyfarth Shaw LLP
  • USA
  • October 24 2018

The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs


The Priority Review Voucher: An Untapped Asset
  • Dilworth IP
  • USA
  • October 3 2018

Typically, we think of patents as the main tool that allows for product exclusivity in the pharmaceutical industry. However, exclusivity has a


PTAB Upholds GILENYA Method of Treatment Patent, Prompting New ANDA Litigation
  • Jones Day
  • USA
  • July 30 2018

In Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109 (Jul. 11, 2018), the PTAB held that the claims of U.S. Patent No. 9,187,405 were not


FDA Issues Final Guidance on Biosimilar Labeling, Sticking with Generic Model
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • July 30 2018

Earlier this month, FDA issued final guidance on the labeling of biosimilar products. The final guidance continues the approach adopted in FDA’s March


Washington Healthcare Update - May 21, 2018
  • McGuireWoods LLP
  • USA
  • May 21 2018

On May 17, the Energy and Commerce Committee held the second of its opioid legislation markups, clearing 32 bills. The previous markup reported out 25


ITC Institutes Investigation Based on Allegation of Drug Sales Without FDA Approval
  • Jones Day
  • USA
  • May 17 2018

Normally, it is the FDA that monitors the improper distribution of drugs. But, as it turns out, the International Trade Commission ("ITC") might be


FDA Publishes List of Drug Companies Accused of Hindering Generic Entry: Antitrust Implications
  • Wilmer Cutler Pickering Hale and Dorr LLP
  • USA
  • May 17 2018

Today, as part of the Trump Administration's stated goal to lower drug prices, the Food and Drug Administration (FDA) published a list of