Strictly Business
JANUARY 25, 2024
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, meeting minutes, and other resolutions. Contracts with customers and vendors. This article is for general information only.
FDA Law Blog
SEPTEMBER 27, 2023
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.
FDA Law Blog
SEPTEMBER 20, 2021
The discussion and public comments during this workshop will inform a new strategy document with actions the Agency will take during PDUFA VII to advance the utilization of innovative manufacturing technology. Now formalized, this request should be submitted by a sponsor within 20 calendar days of receipt of the meeting minutes or WRO.
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