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Introductory OTC Documentation A highly practical half-day workshop introducing participants to the ALMA Online Guide to OTC Documents, an online publication that provides standardized documentation
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What is introductory otc documentation?
Introductory OTC documentation is a form required to be filed by new over-the-counter (OTC) drug products before they can be legally marketed.
Who is required to file introductory otc documentation?
The manufacturer or distributor of a new OTC drug product is required to file introductory OTC documentation.
How to fill out introductory otc documentation?
Introductory OTC documentation can be filled out online through the respective regulatory authority's website or by submitting a physical form with the required information.
What is the purpose of introductory otc documentation?
The purpose of introductory OTC documentation is to provide regulatory authorities with essential information about a new OTC drug product before it is marketed to ensure its safety and efficacy.
What information must be reported on introductory otc documentation?
Information such as the drug product's formulation, intended use, active ingredients, labeling, and manufacturing process must be reported on introductory OTC documentation.
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