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Current trends in the FDA's enforcement of GMP requirements
  • Jones Day
  • USA
  • March 15 2013

Drugs and devices are "adulterated," as that term is used in the Food, Drug, and Cosmetic Act, if the drugs and devices are contaminated, impure, or


Regulatory and legislative responses to drug shortages
  • Jones Day
  • USA
  • August 22 2012

Over the past year, the problem of drug shortages has received markedly increased attention from the federal government.


Review of the Food and Drug Administration Safety and Innovation Act of 2012
  • Jones Day
  • USA
  • July 31 2012

On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act ("FDASIA"), Pub. L. No. 112-144, 126 Stat. 993 (2012).


Do compounding pharmacies "live in sin"? The FDA's assertion of enforcement authority over pharmacy compounding, and two courts' efforts to bless the practice
  • Jones Day
  • USA
  • November 1 2011

Pharmacy compounding, as the Food and Drug Administration ("FDA") explains, "is an age-old practice in which pharmacists combine ingredients to create unique medications that meet specific needs of individual patients."


Certain post-approval activities to support submissions to the FDA are now subject to claims of patent infringement
  • Jones Day
  • USA
  • September 20 2011

On August 31, the Federal Circuit significantly restricted the scope of the "safe harbor" provision of 35 U.S.C. 271(e)(1), which immunizes the use of patented inventions in connection with regulatory submissions to the Food and Drug Administration ("FDA").


President Obama proposes reducing the exclusivity period of brand-name biological products
  • Jones Day
  • USA
  • September 20 2011

President Obama, in his new budget plan, proposes reducing the exclusivity period for brand-name biologics from 12 years to seven.


Is your smart phone an FDA-regulated medical device?
  • Jones Day
  • USA
  • August 3 2011

An enormous number of software applications have been developed for use on handheld computers such as smart phones, tablet computers, and personal digital assistants.


New regulations expand FDA's power to seize food; require additional disclosures from food importers
  • Jones Day
  • USA
  • July 1 2011

On January 4, 2011, President Obama signed into law the Food Safety Modernization Act ("FSMA").


Recalls of FDA-regulated products - do you need to call the FDA?
  • Jones Day
  • USA
  • June 9 2011

Almost every day, the Food and Drug Administration announces product recalls.