Life Sciences Product Approval Representation and Warranty Clause


Summary

This Life Sciences Product Approval Representation and Warranty Clause from the seller discloses the status of relevant product approvals. This template includes practical guidance, drafting notes, and alternate clauses. In the United States, pharmaceuticals and biologics must, in most cases, be approved by the FDA before they can be marketed to the public. Novel pharmaceutical products are typically approved pursuant to a new drug application, or "NDA". Generic pharmaceuticals are typically approved through a more streamlined process pursuant to an abbreviated new drug application or "ANDA". Similarly, biologics are approved pursuant to a biologic license application or "BLA" and biosimilar products are approved pursuant to an abbreviated BLA process. Except in the case of Class I devices, such as simple bandages and tongue depressors, medical device manufacturers are required to submit either a premarket notification under Section 510(k) of the Federal Food Drug and Cosmetics Act or ...