Quality & Compliance: Tell Me a Story
Posted 01 October 2010 | By
Regulatory professionals routinely produce and submit documents to regulatory agencies that introduce a healthcare product or technology and/or provide scientific information for agency consideration. The goal of these submissions may be to obtain agency feedback or guidance on a particular issue or to provide data upon which the agency can base a regulatory action decision (e.g., the sponsor may proceed with a clinical study, the product is approved for marketing, the change in manufacturing is approved, etc.).