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Editor’s Note: FDAnews Device Daily Bulletin

April 9, 2020

Editor’s Note: Due to a spring holiday, FDAnews Device Daily Bulletin will not be published Friday, April 10. The next issue will be published Monday, April 13.

10Aug
Gene & Cell Therapy Regulation: Comparability and Other New Developments
08Sep
Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections
15Sep
Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis
20Sep
Building a World-Class Pharmaceutical Advertising and Promotion Review Program
21Sep
The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval
22Sep
FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

Editor’s Note: FDAnews Device Daily Bulletin

Upcoming Events

Gene & Cell Therapy Regulation: Comparability and Other New Developments

Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

Building a World-Class Pharmaceutical Advertising and Promotion Review Program

The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

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FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

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