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The Westin Boston Waterfront

Aug 13, 2018 7:45 AM - Aug 16, 2018 5:00 PM

425 Summer Street, Boston, MA 02210

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

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Session 26: Resources for Regulatory Intelligence

Session Chair(s)

Michael Hamrell, PhD, RAC

Michael Hamrell, PhD, RAC

President

MORIAH Consultants, 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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