Drugs Glossary Definition (English)
Tentative Approval Defined
The following is in context to Drugs, because it's common for a single word to have multiple meanings you will find additional research links near the bottom of the page.
"If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA issues a tentative approval letter to the applicant. The tentative approval letter details the circumstances associated with the tentative approval. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product."
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Additional Tentative Approval Definition Starting Points
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Expert Dictionary: Tentative Approval
Dictionary: Tentative Approval
