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Results: 1-10 of 63

Rare Pediatric Disease Clinical Trials Get New Lift from EMA-Inspired Gaucher Model
  • Arent Fox LLP
  • USA
  • December 13 2017

On December 6, 2017, FDA announced a new approach for pediatric disease drug development that the Agency believes will reduce the number of patients


FDA Issues Comprehensive Tissue Product Regulatory Framework
  • Arent Fox LLP
  • USA
  • November 21 2017

On November 16, 2017, FDA announced a comprehensive regenerative medicine policy framework to provide additional clarity regarding existing and future


Companies Marketing CBD Products Be Warned: FDA Is Watching
  • Arent Fox LLP
  • USA
  • November 20 2017

The US Food and Drug Administration recently issued warning letters to four companies - Stanley Brothers Social Enterprises LLC, Greenroads Health


FTC Holds Public Workshop to Consider If Hatch-Waxman Is Working for Prescription Drug Competition
  • Arent Fox LLP
  • USA
  • November 13 2017

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply


FDA Announces “New” Framework to Regulate Stem Cell Therapies and Regenerative Medicine
  • Arent Fox LLP
  • USA
  • September 8 2017

Last week, FDA Commissioner Gottlieb issued a statement describing the Agency’s “new” policy for regulating stem cell therapies and regenerative


FDA Trip Leads to Securities Stumble: The Gravity of Regulatory Due Diligence
  • Arent Fox LLP
  • USA
  • September 7 2017

After three years of litigation, a medical device manufacturer has agreed to pay $7 million to settle a class action lawsuit that claimed the company


Court Upholds FDA’s Authority to Regulate E-Cigarettes
  • Arent Fox LLP
  • USA
  • August 1 2017

On July 21, the US District Court for the District of Columbia upheld FDA’s authority to regulate e-cigarettes and other electronic nicotine delivery


Consumer Groups File False Advertising Suit Over ‘100 Natural’ Claim, Alleging Residues in Poultry
  • Arent Fox LLP
  • USA
  • July 5 2017

Continuing a trend that is certain to keep growing, three consumer groups recently filed a lawsuit against Sanderson Farms alleging false advertising


Will Opioid Manufacturers Become the Next Big Tobacco?
  • Arent Fox LLP
  • USA
  • June 30 2017

With the federal response to the opioid crisis still under development, state and local governments continue to file lawsuits against the


FDA Publishes Action Plan Designed to Address Generic Drug Competition Barriers
  • Arent Fox LLP
  • USA
  • June 28 2017

On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have