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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: LLCF who wrote (417)	10/7/1999 10:44:00 AM
From: biowa	Read Replies (2) \| Respond to of 52153

DAK, For those long CLTR, we may find the following Adobe(R) PR on FDA applications interesting (for the irony and possibly enlightenment). biowa **** U.S. Food & Drug Administration Speeds Review of New Drug Applications With Abobe Acrobat and PDF Faster Processing, Easier Management of Documents Can Reduce Review Time <> SAN JOSE, Calif., Oct. 6 /PRNewswire/ -- The review of new drug applications (NDAs) is undergoing a revolution at the U.S. Food and Drug Administration (FDA). With the help of Adobe(R) Acrobat(R) and PDF, NDAs for everything from life-saving medications to basic over-the-counter treatments are processed faster and more efficiently than ever. The benefits are undeniable -- FDA staff can share information and review documents in minutes versus days, volumes of data are easier to manage and archive, consumers get faster access to breakthrough medications, and drug companies can release promising medications sooner, possibly increasing their daily revenues by millions of dollars. Pharmaceutical companies submit thousands of NDAs annually to the FDA, with the hopes of introducing new drugs, changing recommended dosages, or marketing medications for different therapies. A typical NDA contains extensive pharmacology reports and results from clinical trials, often bound in as many as 1,000 volumes with 300 pages each. "Adobe Acrobat and PDF support on-line access to NDA submissions that simplifies distributing, locating, and archiving this huge volume of data, " says Greg Brolund, associate director for technology and policy for the Center for Drug Evaluation and Research at the FDA. "These efficiencies can help reduce the time to review NDA submissions and lower our processing costs." Smoother Workflow with Acrobat 4.0 The enhanced capabilities of Adobe Acrobat 4.0 software promise to further streamline the FDA's already efficient processes. For example, new annotation features -- text highlighting, digital signatures -- will make it easier for FDA staff to share and view comments from other members of a review team, and determine who still needs to provide input. Additionally, the ability to copy charts from PDF files on a PC to Microsoft Word or Microsoft Excel and view different versions of PDF files side by side will streamline the creation of review documents, which FDA reviewers create to highlight key findings in each NDA. An Economic Advantage In late 1997, the FDA started giving pharmaceutical companies the option of submitting NDAs in Adobe PDF instead of on paper. Since then, the agency has received PDF submissions containing more than seven million pages in total. For pharmaceutical companies, the advantages to using Adobe Acrobat and PDF are many. First, the days or weeks needed to manually assemble hundreds of thousands of pages of research documents are eliminated. Second, photocopying and shipping costs, which can run upwards of $10,000 for a single submission, are cut substantially. And finally, more rapid approval on NDAs for critical medications can translate into increased revenue for pharmaceutical companies, sometimes at the rate of one million dollars per day. Benefits Now and in the Future The FDA plans to maintain indefinitely a PDF library of NDA submissions and review documents. In doing so, the agency will have an accessible, easy-to-manage repository of drug history information, which is especially useful since drug manufacturers frequently submit changes -- for new dosages, different therapeutic applications -- to already approved medications. As Brolund sees it, the increasing use of Adobe Acrobat and PDF is a natural extension of the agency's, and pharmaceutical industry's, push for better, more streamlined operations. "Acrobat gives us a foundation for improving how we work today and in the future. When our reviewers can quickly find the information they need to make decisions, our service and effectiveness as a government agency go up considerably."