compiled by Angela Godwin

FDA releases new draft guidance

The FDA has released its draft guidance Review & Inspection of Premarket Approval Application Manufacturing Information & Operations [Docket No. 2006D-0063] in a continuing effort to improve scheduling and timeliness of preapproval inspections. The draft guidance is not final, nor is it in effect at this time.

The document, officials stress, is intended to assist manufacturers in preparing for FDA review of their premarket approval application (PMA) manufacturing section, and in the coordination of the preapproval inspection of the manufacturing operations described in the PMA or PMA supplement.

To obtain a copy of the draft guidance (document number 1566), send an e-mail request to [email protected] or fax a request to (240) 276-3151 to receive a hard copy. The deadline for public comment is September 18, 2006.

Nanodiamond technology enhances flat screen displays

NanoFED, a subsidiary of Advance Nanotech, Inc., in collaboration with the University of Bristol, has filed for four further patent applications of its core nanodiamond technology in the U.S., E.U., Japan and South Korea. NanoFED has an exclusive license from Bristol University for the commercial exploitation of the technology. The University and firm are also planning to file additional new patent applications for components related to its lithiated nanodiamond field emission device that have been developed as part of the NanoFED program.

NanoFED is developing a disruptive Field Emission Display (FED) technology, offering low-voltage, highly uniform, rugged displays, compatible with existing manufacturing lines. The significant advantage of the nanodiamond emitter material is that it can tolerate packaging processing steps traditionally used in CRT manufacture, leading to significantly better yields and operational stability.


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