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Sheraton Philadelphia University City

Oct 22, 2018 1:45 PM - Oct 25, 2018 11:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

Regulatory Affairs: The IND, NDA, and Post-Marketing

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Session 26: Resources for Regulatory Intelligence

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

What is the Freedom of Information Act

Finding Regulatory Information on the FDA website
Key Approval Documents
Advisory Committee Meeting Information
Laws, Regulations, and Guidance
FDA Enforcement Actions

Other Important FDA related websites:

Regulations.gov; Federalregister.gov;Clinicaltrials.gov; Dailymed.nlm.nih.gov

Other health authority websites

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