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Results:1-10 of 57

More gluten-free micro-brews in our future?
  • Alston & Bird LLP
  • USA
  • August 14 2014

The U.S. Food and Drug Administration (FDA) issued a Final Rule last August establishing a federal standard for "gluten-free" labeling of foods. That


FDA’s “Mobile Medical Apps” Guidance: What’s in? What’s out?
  • Alston & Bird LLP
  • USA
  • September 27 2013

This week, the U.S. Food and Drug Administration (FDA) released its Final Guidance on Mobile Medical Applications, revamping its Draft Guidance and


FDA’s final produce standards to require assessment of environmental impact
  • Alston & Bird LLP
  • USA
  • August 16 2013

On Monday, August 19, the Food and Drug Administration (FDA) will publish a notice of intent (NOI) to prepare an environmental impact statement (EIS)


FDA introduces proposals to strengthen safety profile of imported foods
  • Alston & Bird LLP
  • USA
  • August 1 2013

This advisory is published by Alston & Bird LLP to provide a summary of significant developments to our clients and friends. It is intended to be


FDA streamlines CGMP compliance for combination products
  • Alston & Bird LLP
  • USA
  • January 24 2013

On January 22, 2013, the U.S. Food and Drug Administration (FDA) published its final rule implementing current good manufacturing practice (CGMP)


FDA acceptance policies on PMA and 510(k) submissions
  • Alston & Bird LLP
  • USA
  • January 14 2013

On December 31, 2012, FDA issued two guidance documents detailing the agency's approach to reviewing the completeness of medical device applications


Regulatory implementation activities
  • Alston & Bird LLP
  • USA
  • November 15 2012

FDA will continue implementation of FDASIA (“PDUFA V”) by moving forward with a variety of pending rules, most notably for the newly established generic drug user fee program.


On the horizon what to expect from FDA in 2013
  • Alston & Bird LLP
  • USA
  • November 15 2012

With the reelection of President Obama, the U.S. Food and Drug Administration (FDA) is likely to continue its current high level of regulatory oversight and enforcement.


Ripe for congressional reform
  • Alston & Bird LLP
  • USA
  • November 15 2012

In response to the NECC fungal meningitis outbreak, Representative Edward Markey (D-MA) introduced new legislation to expand FDA authority over prescription drug compounders.


FDA moving forward with planned consumer study of disease information presented in branded prescription drug promotion, placing industry on notice
  • Alston & Bird LLP
  • USA
  • July 19 2012

Last month, the U.S. Food and Drug Administration (FDA) announced that it is seeking approval from the Office of Management and Budget (OMB) to move forward with conducting a study of consumer perceptions of disease information included in branded prescription drug advertising.