Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Part 11: FDA plans to publish draft guidance on use of computerized systems in clinical trials by the end of August. The "Part 11" draft guidance will replace a guidance on the same topic published in April 1999 and align the guidelines with policy articulated in FDA's broader guidance released in August 2003: "Part 11, Electronic Records; Electronic Signatures - Scope and Application" (1"The Gray Sheet" Sept. 8, 2003, In Brief). The forthcoming draft guidance is expected to outline general principles that should be followed when computerized systems are used to create, modify, maintain, archive, retrieve or transmit clinical trial data to ensure that electronic records meet regulatory standards and requirements. Many of the guidance's general principles are expected to address clinical trial electronic record security...

You may also be interested in...



Regulatory News In Brief

CDRH's Kessler on public radio: "Stents are fantastic inventions by medical device companies. I just don't think that the public has any clue that this industry is out there. People talk - with all respect to my sister agency - drugs, drugs, drugs and those are wonderful, but there is technology out there that is really working and the medical device field is outstanding," Office of Science & Engineering Laboratories Director Larry Kessler remarked during an Oct. 6 Kojo Nnamdi Show highlighting the CDRH science office. Later, Kessler alluded to fake Prolene surgical mesh manufactured by a company in India. OSEL testing found that although the counterfeiter's attempt at the J&J product did have some sterility problems, it largely worked as intended. Kessler also discussed timing for OSEL research: "We try to start studies that we do that are going to reflect products that come into the agency for approval anywhere from one to as much as five years ahead of time." Kessler added: "We have been doing a lot of work, for example, in laser diagnosis - that is, using light to diagnose conditions. We are trying to really move ahead, and some of these studies take six months to a year, sometimes two" years...

Regulatory News In Brief

CDRH's Kessler on public radio: "Stents are fantastic inventions by medical device companies. I just don't think that the public has any clue that this industry is out there. People talk - with all respect to my sister agency - drugs, drugs, drugs and those are wonderful, but there is technology out there that is really working and the medical device field is outstanding," Office of Science & Engineering Laboratories Director Larry Kessler remarked during an Oct. 6 Kojo Nnamdi Show highlighting the CDRH science office. Later, Kessler alluded to fake Prolene surgical mesh manufactured by a company in India. OSEL testing found that although the counterfeiter's attempt at the J&J product did have some sterility problems, it largely worked as intended. Kessler also discussed timing for OSEL research: "We try to start studies that we do that are going to reflect products that come into the agency for approval anywhere from one to as much as five years ahead of time." Kessler added: "We have been doing a lot of work, for example, in laser diagnosis - that is, using light to diagnose conditions. We are trying to really move ahead, and some of these studies take six months to a year, sometimes two" years...

Abbott/Wyeth drug monitoring test

510(k) submission for Abbott's automated test to monitor Rapamune (sirolimus) renal transplant anti-rejection drug response is submitted to FDA under a 2003 collaboration with drug maker Wyeth. Manufacturing partner Axis-Shield is responsible for regulatory clearance. The test will run on Abbott's IMx automated immunoassay analyzer. Abbott already offers tests for cyclosporine and tacrolimus immunosuppressant monitoring. FDA currently is preparing to issue guidance outlining Class II special controls for sirolimus test systems after recently approving Microgenics' Cedia sirolimus assay via the de novo review process (1"The Gray Sheet" Aug. 23, 2004, p. 17)...

Related Content

UsernamePublicRestriction

Register

MT020777

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel