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Sheraton Philadelphia University City

Oct 14, 2019 7:45 AM - Oct 17, 2019 5:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

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

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

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Session 26: Resources for Regulatory Intelligence

Session Chair(s)

Carol H. Danielson, DrPH, MS, RAC

Carol H. Danielson, DrPH, MS, RAC

President

Regulatory Advantage, LLC, 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

Submitting an FOI Request

Important FDA Related Websites:

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

Other Health Authority Websites

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