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FDA Open to Suggestions for Overcoming Drug Development Obstacles

NEW YORK, April 22 (GenomeWeb News) - The US Food and Drug Administration has established a public docket to obtain information on the major hurdles in drug, device, and biologic development, and to solicit proposed solutions.


The docket encourages input from industry, patients, academics, investors, and all other interested parties to be submitted via letter or electronically by July 30. All submitted material will be publicly available.


The FDA first outlined the initiative in a March 16 white paper that noted a decline in the number of new drug, biologic, and medical device applications, despite the recent boom in genomics, proteomics, bioinformatics and related technologies.

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