_episode-6-deficiency-notices-amp-regulatory-information-requests.jpg "Episode 6: Deficiency Notices & Regulatory Information Requests from qxp Video Screenshot Preview")
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⏲ Duration: 3 min 36 sec
✓ Published: 01-Sep-2020
✓ Published: 01-Sep-2020
Description:
Development organizations, and in particular start-ups often have very small regulatory teams, commensurate with the size of the rest of their staff.nnHowever, when filing for a novel product or indication, regulatory feedback, requests for information and even deficiency notices such as the FDAs CRL or Complete Response Letter can be commonplace.nnDealing with regulatory agencies in written form, in teleconference or face to face all have unique challenges.nnQxP engages with career profession
Development organizations, and in particular start-ups often have very small regulatory teams, commensurate with the size of the rest of their staff.nnHowever, when filing for a novel product or indication, regulatory feedback, requests for information and even deficiency notices such as the FDAs CRL or Complete Response Letter can be commonplace.nnDealing with regulatory agencies in written form, in teleconference or face to face all have unique challenges.nnQxP engages with career profession
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