Supporting documentation


Pharmaceutical Development Study

Supporting documentation

OMB: 0910-0604

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Attached are the following documents or web addresses for documents to support our position on collecting information under the Pharmaceutical Development Study.

(1) Janets Woodcock’s (deputy commissioner of the fda) presentation at FDA Science Board

(2) Critical Path Initiative

(3)Report from Pharmaceutical CGMP for the 21st Century Initiative

(4) Presentations on quality by design

5) Federal Register Notice on CMC Pilot for QbD for new drugs

(6) CTD guidance

(7) Guidance on process analytical technologies

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Last Modified Byeberbako
File Modified2007-02-28
File Created2007-02-28

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