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Results:1-10 of 37

Another One Bites the Dust: FDA doesn’t like the fishy smell of the latest court decision on off-label dissemination
  • Arnall Golden Gregory LLP
  • USA
  • August 19 2015

The Food and Drug Administration has lost yet another court decision challenging its ability to restrict a company's commercial free speech rights


Georgia Senator introduces the Combination Product Regulatory Fairness Act of 2015
  • Arnall Golden Gregory LLP
  • USA
  • July 21 2015

On July 17, 2015, Georgia's U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a


Expanded access to unapproved drugs recast: FDA simplifies compassionate use application process
  • Arnall Golden Gregory LLP
  • USA
  • February 17 2015

On February 10, 2014, the Food and Drug Administration (FDA) announced in the Federal Register the release of a new draft guidance that makes changes


Key FDA guidance documents for section 503B outsourcing facilities
  • Arnall Golden Gregory LLP
  • USA
  • December 17 2014

In late November, 2014, the Food and Drug Administration (FDA) released two final guidance documents and one revised draft guidance relating to drug


FDA issues final guidance defining circumstances that constitute delaying, denying, limiting or refusing a drug inspection
  • Arnall Golden Gregory LLP
  • USA
  • October 30 2014

Under the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in 2012, a drug is adulterated if it "has been manufactured


Latest developments on FDA regulation of laboratory developed tests
  • Arnall Golden Gregory LLP
  • USA
  • October 28 2014

On July 31, 2014, the Food and Drug Administration provided Congress a 60-day notice of the agency's intent to issue guidance on the regulation of


FDA issues Final Guidance on Evaluating Substantial Equivalence in 510(k) submissions
  • Arnall Golden Gregory LLP
  • USA
  • August 12 2014

On July 28, 2014, the U.S. Food and Drug Administration (FDA) released a final guidance entitled "The 510(k) Program: Evaluating Substantial


FDA presents plans to ensure the reliability of laboratory-developed diagnostic tests
  • Arnall Golden Gregory LLP
  • USA
  • August 4 2014

On July 31, 2014, the U.S. Food and Drug Administration (FDA) took important steps to ensure that certain tests used by health care professionals to


FDA issues guidance for mobile medical applications
  • Arnall Golden Gregory LLP
  • USA
  • October 11 2013

The number of mobile medical applications for use on smartphones and tablets is growing rapidly as more and more app developers release new products


Get back to where you once belonged: FDA wins lawsuit to rescind 510(k)
  • Arnall Golden Gregory LLP
  • USA
  • June 13 2013

The Food and Drug Administration recently won an important court victory that allowed the agency to rescind a medical device's premarket notification