SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

Electronic Drug Registration & Listing Using CDER Direct – Files

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Evaluation & Certificate

October 5:

KEYNOTE: The New 207 and What You Need to Know
Leyla Rahjou Esfandiary
Slides in ZIP file above
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Sesion 1: Establishment Registration
Regie Samuel & Troy Cu
Slides in ZIP file above
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Session 2: Labeler Code Request
Lalnunpuii Huber & David Mazyck
Slides in ZIP file above
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Session 3: Drug Product Listing
Julian Chun & Tasneem Hussain
Slides in ZIP file above
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Session 4: Listing Recertification
Donovan Duggan
Slides in ZIP file above
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Session 5: 503B Product Reporting for Compounding Outsourcing Facilities
Lysette Deshields & Soo Jin Park
Slides in ZIP file above
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CLOSING
Paul Loebach
Slides in ZIP file above
Recorded as part of above.