We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
In cooperation with Association of Corporate Counsel
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 1-10 of 29

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New draft guidance on quality agreements: no passing the buck on CGMPs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Last week, FDA released a draft guidance document entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."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FDA issues a draft guidance for industry and FDA staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff.".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On July 13, 2012, FDA issued a Draft Guidance for Industry and FDA Staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff."

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

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

Policy & Hill update

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

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

FDA revisiting REMS draft guidance and overall policy in upcoming public meeting

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

The agency recently announced an upcoming, two-day public meeting July 27-28 to solicit stakeholder feedback on the issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biologics

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