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A seller will typically receive requests for items such as: Corporate documents, including incorporation or formation records and related shareholder or member agreements, capitalization tables, meetingminutes, and other resolutions. Contracts with customers and vendors.
FDA intends to respond to a Type D meeting request within 14 days from receipt and to schedule a meeting or issue written responses within 50 days of receipt of a request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date.
These alternative tools have included requesting records and other information from facilities/sponsors, using information and inspection reports from foreign regulatory authorities, and alternative technology platforms. Finally, FDA will hold a public workshop on meeting management.
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