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Results: 1-10 of 196

The FDA Faces Challenges to its New Regulations for E-Cigarettes
  • Weil Gotshal & Manges LLP
  • USA
  • August 2 2016

We recently reported that the Food and Drug Administration (“FDA”) issued a final ruling regarding the regulation of electronic cigarettes


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 9
  • Jones Day
  • USA, European Union
  • June 17 2016

FDA has published its last major regulation implementing the Food Safety and Modernization Act ("FSMA"): a final rule on mitigation strategies to


FDA sets allowable level for DEHP in bottled water
  • Shook Hardy & Bacon LLP
  • USA
  • October 21 2011

The Food and Drug Administration (FDA) has announced changes to its bottled water quality standard “by establishing an allowable level for the chemical di(2-ethylhexyl)phthalate (DEHP).”


The Institute of Medicine recommends FDA abandon the 510(k) premarket clearance process
  • Latham & Watkins LLP
  • USA
  • August 2 2011

In September 2009, the US Food and Drug Administration (FDA or Agency) requested that the Institute of Medicine (IOM) evaluate the premarket clearance process for medical devices set forth in section 510(k) of the Federal Food, Drug and Cosmetic Act


FDA seeks comments on whether FDA-regulated products involve the application of nanotechnology
  • Shook Hardy & Bacon LLP
  • USA
  • June 24 2011

The U.S. Food and Drug Administration (FDA) has issued draft guidance “intended to help industry and others identify when they should consider potential implications for regulatory status, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products.”


FDA's guidelines for petitions filed under section 505(q) of Food, Drug, and Cosmetic Act
  • Duane Morris LLP
  • USA
  • June 16 2011

The U.S. Food and Drug Administration (FDA) recently published its guidelines related to citizen petitions and petitions for stays of action under section 505(q) of the federal Food, Drug, and Cosmetic Act (a "Petition"


FDA requests input on user fee program for biosimilar and interchangeable biological products
  • Arnall Golden Gregory LLP
  • USA
  • May 25 2011

The U.S. Food and Drug Administration (FDA) announced this month that it is seeking industry and stakeholder input on the development of a user fee program for biosimilar and interchangeable biological products


FDA: hand sanitizer, antiseptic claims false
  • Manatt Phelps & Phillips LLP
  • USA
  • May 12 2011

The Food and Drug Administration sent letters to four companies warning them that they were violating the Food, Drug, and Cosmetic Act by claiming their hand sanitizers and antiseptic products are effective in preventing infections


The FDA issues its first two regulations implementing the Food Safety Modernization Act
  • Roetzel & Andress
  • USA
  • May 12 2011

On May 4, 2011, the Food and Drug Administration (FDA) issued the first of its new regulations implementing the Food Safety Modernization Act (FSMA) enacted into law in January


Dietary supplement firms, CGMPs and the park doctrine
  • Saul Ewing Arnstein & Lehr LLP
  • USA
  • April 12 2011

As FDA continues to inspect dietary supplement manufacturers under the new CGMP framework, it is clear that many manufacturers share similar deficiencies