Difference between revisions of "Application (RPS)"
Joelfinkle (talk | contribs) (New page: {{Category:RPS Glossary}} == RPS Application == This is a Glossary page ==R1 Working Definition== Collection of related Regulatory Activities (RPS1 "Submissions"). ==...) |
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==BRIDG Term== | ==BRIDG Term== | ||
| − | Reglatory Application - A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance. | + | '''Reglatory Application''' - A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance. |
For example, the marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action. | For example, the marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action. | ||
NOTE: Over time, an application will typically consist of multiple submissions and regulatory assessments | NOTE: Over time, an application will typically consist of multiple submissions and regulatory assessments | ||
Revision as of 16:13, 19 September 2008
Main Page | Regulated Clinical Research Information Management | Regulated Product Submissions | RPS Glossary
This page provides a list of Definitions for the RPS project. RPS Definitions are suffixed with "(RPS)" to avoid confusion with other projects' definitions on this Wiki.
This article is under construction
RPS Application
This is a Glossary page
R1 Working Definition
Collection of related Regulatory Activities (RPS1 "Submissions").
ICH Equivalent
None
BRIDG Term
Reglatory Application - A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance.
For example, the marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action.
NOTE: Over time, an application will typically consist of multiple submissions and regulatory assessments
