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PAC FORM #2 COURSE IMPLEMENTATION DATE: Revised: May 2000 COURSE TO BE REVIEWED DATE: (Four years after implementation date) January 1997 September 2004 OFFICIAL COURSE OUTLINE INFORMATION Students
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What is bio 416?
Bio 416 is a form used to report information on biological products, including vaccines, to regulatory authorities.
Who is required to file bio 416?
Manufacturers, packagers, labelers, and distributors of biological products are required to file bio 416.
How to fill out bio 416?
Bio 416 can be filled out electronically through the FDA's Electronic Submission Gateway (ESG) or manually by submitting a paper form.
What is the purpose of bio 416?
The purpose of bio 416 is to track and monitor the distribution and safety of biological products in the market.
What information must be reported on bio 416?
Information such as product name, manufacturer, lot number, expiration date, and adverse reactions must be reported on bio 416.
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