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CPSC Enforcement Trends to Watch: Increased Focus on Child Resistant Packaging and Certificates of Compliance
  • Keller and Heckman LLP
  • USA
  • November 12 2018

We have observed two recent enforcement trends at the Consumer Product Safety Commission (CPSC) that may affect the e-vapor industry: (1) a spike in

Bill Requiring Disclosure of Biosimilar Settlement Agreements to the FTC and DOJ Becomes Law
  • Patterson Belknap Webb & Tyler LLP
  • USA
  • October 29 2018

Earlier this month, the President signed into law the Patient Right to Know Drug Prices Act (Public Law 115-263). The Act mainly focuses on

Akorn v. Fresenius: Important Practical Lessons from First-Ever Material Adverse Effect
  • Fenwick & West LLP
  • USA
  • October 24 2018

On October 1, in Akorn v. Fresenius Kabi, the Delaware Court of Chancery for the first time found that a material adverse effect or MAE had

FTC and Deceptive Advertising Claims Regarding Stem Cell Therapy
  • Baker McKenzie
  • USA
  • October 23 2018

On 18 October 2018, the Federal Trade Commission (FTC) announced that it had reached a settlement prohibiting two companies, Regenerative Medical

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads
  • Mintz
  • USA
  • October 17 2018

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week

Washington Healthcare Update- 8 Oct, 2018
  • McGuireWoods Consulting LLC
  • USA
  • October 8 2018

D.C. obsessed with Supreme Court nomination; opioids legislation hits the president’s desk for signature; 340B continues to be of concern

Infrared Protection Claims Rub NAD the Wrong Way
  • Baker & Hostetler LLP
  • USA
  • October 5 2018

Bayer HealthCare, a manufacturer of sunscreen products, brought complaints against competitor Sea & Ski before the National Advertising Division (NAD) in September...

Consumer Protection in Retail: Weekly Roundup
  • Hunton Andrews Kurth LLP
  • USA
  • September 27 2018

A U.S. district court in Florida has ruled in favor of the FTC in its longstanding litigation against Roca Labs, Inc., a seller of weight-loss powders

FDA enforcement blitz combats underage use of cartridge-based E-Cigarettes and threatens to sack premarket review compliance policy and flavors
  • Keller and Heckman LLP
  • USA
  • September 19 2018

On September 12, 2018, in a self-described “blitz”, FDA announced a deluge of enforcement actions, including more than 1,300 warning letters and fines

FDA Releases Biosimilar Action Plan; Solicits Stakeholder Input; Public Hearing on September 4th
  • Morrison & Foerster LLP
  • USA
  • August 20 2018

On July 18, the FDA released its Biosimilar Action Plan, which focuses on "four key areas:" improving efficiency of the biosimilar and interchangeable