Drugs

Updates to Forms 356h & 1571: Commercial vs. Research, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT), Combination Products

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The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), welcomes you to our webinar series.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation.  The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.
 

On May 4th, FDA updated FDA Forms 1571 and 356h. We are making available this accompanying webinar which provides a description of the latest updates to the FDA’s Forms 356h and 1571 released in May 2018. These changes include identifying if the product is a Commercial IND or Research IND, the identification of Combination Products, and the inclusion of the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT).

This webinar offers a detailed live walk-through of the completed 356h and 1571 forms, with these fields, with mock-data.

Speakers:
Mia Prather
Supervisory Program Analyst
Office of Business Informatics (OBI)
Division of Data Management Services & Solutions
CDER | FDA

Leposava Antonovic, PhD
Science Policy Analyst
Office of New Drugs (OND) – Immediate Office (IO)
CDER | FDA

Melissa Burns
CAPT, US Public Health Service
Senior Program Manager
Office of Combination Products
Office of Special Medical Programs
CDER | FDA

Elizabeth Chen, PharmD
Science Policy Analyst
OND | IO | CDER | FDA

For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707


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