09 May 2023
FDA Controlled Correspondence Checklist
This checklist guides attorneys through drafting and submitting a controlled correspondence to the U.S. Food and Drug Administration (FDA). Controlled correspondence is correspondence submitted to the FDA, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic drug product development.
Related Content
- FDA Complete Response Letters
Learn best practices for responding to a complete response letter (CRL) issued by the FDA.
- FDA Drug Regulatory Activity Tracker
Monitor regulatory action items for matters affecting the pharmaceutical industry including effective dates and compliance dates, deadlines for submitting comments in response to FDA proposed rules and draft guidance, and other key information.
- Life Sciences Product Approval Representation and Warranty Clause
Draft a product approval representation and warranty clause disclosing the status of relevant product approvals. This template includes guidance, drafting notes, and alternate clauses.
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