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Results: 1-10 of 307

Amgen v Apotex - 180-Day Advance Notice of Biosimilar Marketing is Mandatory
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • December 11 2015

The Federal Circuit in July said in its Amgen-Sandoz decision that declining to share information under the biosimilars pathway "patent dance" made


Swarming Regulation of Personal Data in the US Tech Sector
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • January 11 2016

Sectoral regulation of privacy and information security in the United States has created a complex system for tech innovation, because new products


KT is... Product Regulation FDA Compliance
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • January 3 2017

In 2016, the U.S. Food and Drug Administration (FDA) finalized new regulations on Nutrition and Supplement Facts labeling the first revisions since


FDA Recommends Maximum Level of Lead in Cosmetic Products . . . But Finds that Most Products Surveyed are Already Well Below the Recommended Levels
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • December 23 2016

As 2016 comes to an end, the Food and Drug Administration (FDA or agency) is turning its attention to cosmetics by issuing a draft guidance on


FDA Makes Public the Scientific Data Evaluated and Provides Draft Guidance Regarding the Inclusion of Certain Fibers in the Definition of Dietary Fiber
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • December 14 2016

As previously reported here, in May 2016, the Food and Drug Administration (FDA or agency) published new final regulations on Nutrition and Supplement


90-day waiting period and technical changes
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • March 19 2013

Last night the agencies issued proposed regulations on the new 90-day waiting period limitation that applies in 2014 and various technical and


Never fear, PCOR is here
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • June 6 2013

Just like a hero from the latest Star Trek-themed training video, the IRS has released additional PCOR guidance just in time to save the world. As


Forty Years in the Making FDA Issues Propose Rule Requiring Electronic Submission of Labeling and Package Inserts for Class II and Class III Home-Use Medical Devices
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • October 21 2016

This past summer, the Food and Drug Administration (FDA or Agency) celebrated the 40th anniversary of the enactment of the Medical Device Amendments


Correction of health FSA payments
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • March 31 2014

The IRS recently released, CCA 201413006, which is an IRS Chief Counsel Advice Memorandum. It is informal guidance only. This CAA addresses


EEOC files first ever wellness lawsuit
  • Kilpatrick Townsend & Stockton LLP
  • USA
  • August 21 2014

The EEOC wellness rules are almost out, but EEOC is wasting no time in bringing suit against employers who allegedly engage in bad behavior with