CHAPTER 7 Post-notification Filings

• Jurisdiction: United States
• Publication year: 2022

CHAPTER 7 Post-notification Filings Chapter Contents

§7.1 After Submission

§7.1.1 Acknowledgment
§7.1.2 Amendments
§7.1.3 90-Day Publication and Trade Secret Protection
§7.1.4 Failure of FDA to Respond to Notification

§7.2 "Approval" Letter or "Rejection" Letter?

§7.3 Responding to Communications Received from FDA

§7.3.1 Petition to Commissioner
§7.3.2 Request for Reconsideration

§7.4 De Novo Judicial Review

§7.4.1 Basis for de novo Review
§7.4.2 Ripeness for de novo Review
§7.4.3 Scope of de

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