Yesterday, April 4th, 2019, the FDA issued new industry guidance for Risk Evaluation and Mitigation Strategy (REMS). This final guidance clarifies how the FDA applies six factors in determining whether a REMS is required for a particular drug and what type of REMS might be necessary (i.e. what specific elements or tools should be included […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-04-05 10:54:432019-04-05 10:54:43Six Factors that Determine if a REMS is Needed
Rare Diseases: Natural History Studies for Drug Development Guidance On March 22nd, the FDA issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development Guidance for Industry. A natural history study describes the course of a rare disease over time, identifying demographic, genetic, environmental, and other variables that correlate with its development and […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-03-25 10:36:482023-02-02 17:45:49FDA Issues New Guidance for Rare Diseases
These comparisons create a web-like analysis called a Network Diagram or Network Comparison. Other names of NMA include Multiple Treatment Meta-Analysis, Mixed Treatments Comparison, Indirect Treatment Comparison, Pair-Wise Meta-Analysis and so forth. NMA has been widely used in technology appraisals for various clinical indications by technology assessment agencies around the world. For instance, in January […]
Currently, the Sentinel Distributed Database (SDD) is comprised largely of administrative and claims data from health insurers. These large administrative claims databases have become increasingly popular sources of data for comparative safety research (observational studies) because they have several important strengths including a large size, longitudinal data on prescription drug use, generalizability, and low operational […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-02-24 08:30:052019-02-24 08:30:05The Sentinel System for Industrial Use: Strengths and Weaknesses
Recently, FDA has been using RWD from Sentinel System (SS) in drug approval process quite often to evaluate some safety signals in the postmarket setting and also for other purpose. For past three advisory committee meetings hold in January 2019, SS has been applied in two approval processes (Jan 11 and Jan 17 , 2019) […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-02-20 09:37:052019-02-20 09:37:05Using the Sentinel System in FDA Submissions
Six Factors that Determine if a REMS is Needed
in FDA GuidelinesYesterday, April 4th, 2019, the FDA issued new industry guidance for Risk Evaluation and Mitigation Strategy (REMS). This final guidance clarifies how the FDA applies six factors in determining whether a REMS is required for a particular drug and what type of REMS might be necessary (i.e. what specific elements or tools should be included […]
FDA Issues New Guidance for Rare Diseases
in FDA GuidelinesRare Diseases: Natural History Studies for Drug Development Guidance On March 22nd, the FDA issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development Guidance for Industry. A natural history study describes the course of a rare disease over time, identifying demographic, genetic, environmental, and other variables that correlate with its development and […]
What is Network Meta-Analysis (NMA)?
in Network Meta-Analysis Series, Statistical AnalysisThese comparisons create a web-like analysis called a Network Diagram or Network Comparison. Other names of NMA include Multiple Treatment Meta-Analysis, Mixed Treatments Comparison, Indirect Treatment Comparison, Pair-Wise Meta-Analysis and so forth. NMA has been widely used in technology appraisals for various clinical indications by technology assessment agencies around the world. For instance, in January […]
The Sentinel System for Industrial Use: Strengths and Weaknesses
in Statistical AnalysisCurrently, the Sentinel Distributed Database (SDD) is comprised largely of administrative and claims data from health insurers. These large administrative claims databases have become increasingly popular sources of data for comparative safety research (observational studies) because they have several important strengths including a large size, longitudinal data on prescription drug use, generalizability, and low operational […]
Using the Sentinel System in FDA Submissions
in Statistical AnalysisRecently, FDA has been using RWD from Sentinel System (SS) in drug approval process quite often to evaluate some safety signals in the postmarket setting and also for other purpose. For past three advisory committee meetings hold in January 2019, SS has been applied in two approval processes (Jan 11 and Jan 17 , 2019) […]