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Results: 1-10 of 31

FDA finalizes “gluten-free” labeling rule
  • Alston & Bird LLP
  • USA
  • August 5 2013

Today, the U.S. Food and Drug Administration (FDA) issued its much anticipated and long-awaited Final Rule on the "Gluten-Free Labeling of


New draft guidance on quality agreements: no passing the buck on CGMPs
  • Alston & Bird LLP
  • USA
  • June 3 2013

Last week, FDA released a draft guidance document entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements." The guidance


Medical device developments
  • Alston & Bird LLP
  • USA
  • March 4 2013

On February 25, 2013, the U.S. Food and Drug Administration (FDA) issued a proposed rule amending its regulations to update the standards for FDA


Arsenic in your food
  • Alston & Bird LLP
  • USA
  • October 9 2012

A recent report from Consumer Reports magazine asserts that many rice products found on grocery store shelves contain arsenic, a potent human carcinogen


FDA proposes unique device identification (UDI) system for medical devices
  • Alston & Bird LLP
  • USA
  • July 31 2012

On July 10, 2012, the U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register (77 Fed. Reg. 40736) to establish a unique device identification (UDI) system for medical devices


FDA issues a draft guidance for industry and FDA staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff.".
  • Alston & Bird LLP
  • USA
  • July 31 2012

On July 13, 2012, FDA issued a Draft Guidance for Industry and FDA Staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff."


Food safety reform
  • Alston & Bird LLP
  • USA
  • October 28 2010

As the 111th Congress comes to a close, comprehensive food safety reform remains unfinished due to Senate inaction resulting from member objections to the August manager's amendment to S.510


Window closing for comments on FDA transparency proposals
  • Alston & Bird LLP
  • USA
  • June 30 2010

The public comment period soon will end on 21 draft proposals FDA issued regarding its policy on the public disclosure of information in its possession (as weighed against the public interest in maintaining confidentiality of information


Policy & Hill update
  • Alston & Bird LLP
  • USA
  • June 30 2010

Since the passage of health care reform, attention within HHS has turned to implementation


Closing comment periods of note
  • Alston & Bird LLP
  • USA
  • June 30 2010

The U.S. Department of Agriculture (USDA) is seeking comments on the final Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans