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Results:1-10 of 1,945

Slovakia and Czechia: State re-export bans on medicines
  • Abraham & Partneri
  • Slovakia, Czech Republic
  • October 17 2018

As of 1 January 2017, only marketing authorization holder (MAH) of a medicinal product or a distributor with a prior written consent from such MAH can


Oral Argument Held in Deeming Rule Appeal by Nicopure Labs and Right to be Smoke-Free Coalition
  • Keller and Heckman LLP
  • USA
  • September 26 2018

On September 11, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the “Appellants”) appeared for oral argument before a three-judge


Facing Addiction in the Workplace: The Surgeon General’s Spotlight
  • Seyfarth Shaw LLP
  • USA
  • September 25 2018

The U.S. Department of Health and Human Services (HHS), Office of the Surgeon General, has just released a Report on “Facing


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


GDPR: Implementing additional data protection rules in Health Research
  • Arthur Cox
  • European Union
  • September 19 2018

Data controllers conducting "Health Research" must be conscious of the recent signing of the Data Protection Act 2018 (Section 36(2)) (Health


EPA Announces Shift from National Enforcement Initiatives to National Compliance Initiatives
  • Hunton Andrews Kurth LLP
  • USA
  • September 18 2018

As a former regulator (both as an inspector and an attorney, ensuring compliance and enforcing violations) in the environmental law enforcement space


FDA announces continued Kratom safety concerns and issues warning letters to Kratom marketers
  • Keller and Heckman LLP
  • USA
  • September 12 2018

In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about


HHS watchdog eyes anti-kickback safe harbors for care coordination, beneficiary incentives, and cost-sharing
  • Hogan Lovells
  • USA
  • August 29 2018

On Monday, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a wide-ranging Request for Information


FDA Extends Deadline for Comments on Nutrition Innovation Strategy
  • Keller and Heckman LLP
  • USA
  • August 24 2018

At the National Food Policy Conference in March 2018, FDA Commissioner Scott Gottlieb, M.D., announced the creation of the Nutrition Innovation


FDA and Right to Be Smoke-Free Coalition File Briefs Opposing Summary Judgment Motion in Public Health NGOs’ Lawsuit Seeking to Nullify FDA’s PMTA Filing Deadline Extension
  • Keller and Heckman LLP
  • USA
  • August 24 2018

Defendant U.S. Food and Drug Administration (FDA) and the Right to Be Smoke-Free Coalition (RSF) recently submitted briefs to the federal district