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Regulatory Affairs

Cutting Through the Red Tape of Combination Product Approvals

October 11, 2006 8:47 am | Kirkpatrick & Lockhart Nicholson Graham Llp | Product Releases | Comments

As the development and use of combination products increases, the FDA realizes it needs to establish specific guidelines to oversee this technology. This article explores some of the pivotal issues pertaining to how a combination drug-device, drug-biologic, or device-biologic is regulated.

LISTED UNDER: Regulatory Affairs
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New Set of SOPs

November 3, 2004 9:24 am | Product Releases | Comments

The Thomson Center for Clinical Research Practice, Wellesley, MA, has published "Standard Operating Procedures for Good Clinical Practice by Sponsors of Medical Device Research." These SOPs address the unique regulatory and business environment of medical device clinical trials.

LISTED UNDER: Regulatory Affairs

Developing a Strategy for Global Development Teams

November 2, 2004 4:38 am | Product Releases | Comments

A versatile regulatory compliance strategy is crucial to tapping into the expertise of global product development teams. This article outlines four steps to achieving a successful solution.

LISTED UNDER: Regulatory Affairs
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