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From: ButtGaser
Date: 6/22/2002
Time: 11:55:38 AM
Remote Name: 12.245.42.248
I hope that Glaxo did this for Dutasteride, I remember seeing some flow charts. We all know that Dutasteride did not get a six-month priority review status so the sNDA still isn't approved.
USE OF FLOW CHARTS CAN HELP SPEED REVIEW TIMES 03/07/02 10:24 AM by Washington Drug Letter
To speed up drug reviews, companies should create a high level flow chart that leads reviewers through the process of how they will reach the conclusion of safety and efficacy, Joshua Sharlin told an FDAnews audioconference called "Speeding Up FDA Reviews: How to Improve Your Submission Process" March 5.
This can help a firm quickly convey information on the structure and organization of a trial, said Sharlin, a former FDA reviewer. For example, a flow chart can begin with patient recruitment, followed by inclusion or exclusion of patients and patient visits to the clinic, and continue with stages of data creation and analysis.
Sharlin said it is important to remember that a reviewer works in a large organization and, at some point, will need to communicate his analysis to upper management at the FDA. Thus, it is helpful if a drug sponsor provides information in a high-level summary format.
Often firms are completely focused on what is in a guidance document or the Code of Federal Regulations, and once all items are covered they declare victory and send their information for FDA review. But if a drug maker is looking to be efficient with the FDA, it needs to be more creative in tailoring how information is presented and organized, Sharlin said. Firms need to create information that allows reviewers to agree quickly with the firm's conclusion that the drug or device is safe and effective, Sharlin said.
When responding to an FDA reviewer's comments, a firm should reprint the comment and create a clear response, so that the reviewer does not have to refer to any other source to understand the response, he added.
-ButtGaser
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