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Seaport Hotel

Aug 12, 2019 7:45 AM - Aug 15, 2019 5:00 PM

One Seaport Lane, Boston, MA 02210

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)

Drusilla Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., 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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