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Medical device developments

Alston & Bird LLP
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USA
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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
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USA
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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
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USA
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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FDA issues a draft guidance for industry and FDA staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff.".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
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USA
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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On July 13, 2012, FDA issued a Draft Guidance for Industry and FDA Staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff."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
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USA
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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
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USA
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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
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USA
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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
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USA
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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

FDA revisiting REMS draft guidance and overall policy in upcoming public meeting

Alston & Bird LLP
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USA
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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

OIG issues updated recommendations on FDA oversight of foreign clinical trials

Alston & Bird LLP
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USA
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June 30 2010

In September 2001, the Office of Inspector General (OIG) issued a report on "The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects" that detailed the dramatic increase in foreign clinical trials of drug products

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