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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

FDA Issues New Guidance on E-Cigarette Free Samples
  • Klein Moynihan Turco LLP
  • USA
  • October 18 2017

Last week, the Food and Drug Administration (“FDA”) issued finalized guidance regarding the distribution of free samples of e-cigarettes and other

Life sciences: product regulation and liability in the USA
  • Perkins Coie LLP
  • USA, Global
  • October 11 2017

A structured guide to product regulation and liability in the USA

Fraud on the FDA? If Not Preempted, It Is Trumpery
  • Reed Smith LLP
  • USA
  • October 2 2017

With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are

California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products
  • Cooley LLP
  • USA
  • September 18 2017

The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B

Northern District of New York (Quickly!) Holds that the MDA Expressly Preempts Essure Suit
  • Reed Smith LLP
  • USA
  • September 14 2017

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity. That post sprang from an argument before the JPML

FDA and FTC Solicit Consumer Complaints About Dietary Supplement Marketing
  • Pepper Hamilton LLP
  • USA
  • August 7 2017

The Food and Drug Administration and the Federal Trade Commission have jointly requested that consumers report dietary supplements that "didn't work

Three Simple Rules: A Short Course on Marketing and Advertising Your Spirits
  • Lane Powell PC
  • USA
  • August 2 2017

It is hard enough to make good spirits. But if you’re going to meet with commercial success, you can’t afford to stop at simply producing the stuff

Biosimilar Notice May Be Given Prior to FDA Approval
  • McDermott Will & Emery
  • USA
  • June 26 2017

In a unanimous decision, the Supreme Court of the United States explained that under the Biologics Price Competition and Innovation Act of 2009

Dietary Supplement & Cosmetics Legal Bulletin: July 2017
  • Shook Hardy & Bacon LLP
  • USA, European Union
  • June 26 2017

In response to a study analyzing adverse events for cosmetics and personal care products, the Journal of the American Medical Association (JAMA