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The Process of Buying or Selling a Business: A First-Time Seller’s Guide to Due Diligence

Strictly Business

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.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

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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FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law Blog

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.