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- 18:06, 29 September 2008 diff hist +64 N Master File Holder New page: Sponsor which hold a Drug Master File. Category:RPS Glossary current
- 18:02, 29 September 2008 diff hist +185 Abbreviated New Drug Application current
- 18:02, 29 September 2008 diff hist -48 International Conference on Harmonisation →External Links current
- 18:01, 29 September 2008 diff hist +39 International Conference on Harmonisation →External Links
- 17:58, 29 September 2008 diff hist +497 N Abbreviated New Drug Application New page: Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. ...
- 14:58, 29 September 2008 diff hist +2 Drug Master File current
- 14:57, 29 September 2008 diff hist +1,077 N Drug Master File New page: A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or article...
- 14:46, 29 September 2008 diff hist +7 Pre-submission →External Links current
- 14:45, 29 September 2008 diff hist +99 Pre-submission →Additional Regional Definitions and Synonyms
- 14:41, 29 September 2008 diff hist +36 Application Number current
- 14:41, 29 September 2008 diff hist +12 Application Number →Additional Regional Definitions and Synonyms
- 13:56, 29 September 2008 diff hist +73 N SNDA Redirecting to Supplemental New Drug Application
- 19:14, 26 September 2008 diff hist +6 Application Number
- 19:13, 26 September 2008 diff hist +492 N Application Number New page: A unique number assigned by Health Authorities to applications which have been submitted by sponsors for review. ==Additional Regional Definitions and Synonyms== FDA Application Number Th...
- 19:08, 26 September 2008 diff hist +614 N New Drug Application New page: When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits... current
- 19:04, 26 September 2008 diff hist +85 Pre-submission
- 19:03, 26 September 2008 diff hist +85 Supplemental New Drug Application current
- 19:00, 26 September 2008 diff hist +120 N Talk:Pre-submission New page: As defined by the FDA's Current M1 specification for eCTD http://www.fda.gov/cder/regulatory/ersr/Module1Spec.pdf Page 6 current
- 18:59, 26 September 2008 diff hist +76 N Pre-submission New page: Information submitted prior to the submission of a complete new application.
- 18:53, 26 September 2008 diff hist -40 Supplemental New Drug Application
- 18:52, 26 September 2008 diff hist +219 N Supplemental New Drug Application New page: == Supplemental New Drug Application == A Supplemental New Drug Application is an application that when approved will allow a company to make changes in a product that already has an appro...
