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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


(Don’t) Got Milk? FDA Cracking Down on Plant-Based Beverages
  • Bilzin Sumberg
  • USA
  • August 16 2018

At a recent Politico event, Federal Drug Administration (FDA) Commissioner Scott Gottlieb signaled the agency’s shift to a new era of more stringent


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 and FTC Issue 13 Warning Letters to E-liquid Companies for Misleadingly Marketing to Youth; FDA Investigates Youth Use of JUUL Devices
  • Keller and Heckman LLP
  • USA
  • May 2 2018

On May 1, 2018 the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued 13 warning letters to companies that they claim


Win or Go Home? Standing to Appeal PTAB Decisions Upholding Patentability to the Federal Circuit Before Submitting a Biosimilar Marketing Application
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • April 6 2018

Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal


Global Approvals for Insulin Glargine Promise a More Affordable, Long-Acting Treatment for Diabetes
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • April 3 2018

Last week, Mylan N.V. and Biocon Ltd. announced that their jointly-developed insulin glargine biosimilar, Semglee, received marketing approval from


Snack Bar Class Action is KIND-ly Stayed Pending USDA Regulation on Bioengineered Food
  • Proskauer Rose LLP
  • USA
  • March 26 2018

Earlier this month, Judge William H. Pauley III in the Southern District of New York stayed a lawsuit against the snack bar maker KIND LLC, styled as


Drug Price Transparency Bill Enacted in Oregon
  • Cooley LLP
  • USA
  • March 14 2018

The Governor of Oregon signed into law this week House Bill 4005, the Prescription Drug Price Transparency Act (Act). The Act requires manufacturers


FDA Drug Marketing Reports Due February 14, 2018
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • February 12 2018

On February 5, 2018, FDA released a reminder that NDA and ANDA holders’ one-time reports on marketing status under the FDA Reauthorization Act of 2017


Louisiana Adopts Price Reporting Law
  • Kelley Drye & Warren LLP
  • USA
  • November 13 2017

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines