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Results: 1-10 of 191

Pharmaceutical & medical device regulatory update, issue 14

  • Jones Day
  • -
  • USA
  • -
  • September 11 2014

On September 9, 2014, FDA released the first edition of the "Purple Book,"which is the analogue to the Orange Book for biologics. The Orange Book has

Pharmaceutical & medical device regulatory update, issue 13

  • Jones Day
  • -
  • USA
  • -
  • August 28 2014

Hydrocodone with acetaminophen has been the most widely prescribed drug since 2007, with more than 135 million prescriptions written in 2012. Due to

Pharmaceutical & medical device regulatory update, issue 12

  • Jones Day
  • -
  • USA
  • -
  • August 14 2014

On August 4, 2014, FDA issued a draft guidance titled Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act

Food, dietary supplement & cosmetics regulatory update, Issue 11

  • Jones Day
  • -
  • Canada, China, USA
  • -
  • August 8 2014

Last week, a divided federal appeals court ruled that FDA cannot be forced to ban antibiotics in food-producing healthy livestock. Thedecision comes

FDA issues draft guidance on determination of reference product exclusivity for biologics

  • Jones Day
  • -
  • USA
  • -
  • August 7 2014

On August 4, the U.S. Food & Drug Administration ("FDA") issued a draft guidance titled "Reference Product Exclusivity for Biological Products Filed

Pharmaceutical & medical device regulatory update, issue 11

  • Jones Day
  • -
  • USA
  • -
  • July 31 2014

In a significant step for generic biologic products, FDA accepted for review the first application for a biosimilar product. If approved, it could be

Food, dietary supplement & cosmetics regulatory update, issue 10

  • Jones Day
  • -
  • USA
  • -
  • July 24 2014

USDA's Food Safety and Inspection Service ("FSIS") proposed a rulerequiring all makers of raw ground beef products, including retailers that grind

Pharmaceutical & medical device regulatory update, issue 10

  • Jones Day
  • -
  • USA
  • -
  • July 18 2014

Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight

Pharmaceutical & medical device regulatory update, issue 9

  • Jones Day
  • -
  • USA
  • -
  • July 1 2014

In a draft guidance issued on June 20, FDA announced it does not intend to enforce compliance with regulations governing medical device data systems

FDA finalizes guidance document on Expedited Programs for Serious Conditions

  • Jones Day
  • -
  • USA
  • -
  • June 27 2014

On May 30, 2014, FDA finalized its Guidance for Industry: Expedited Programs for Serious Conditions - Drugs and Biologics. The draft guidance