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A sponsor sends a feasibility questionnaire to the local research site. The Clinical Research Coordinator completes the form on behalf of the site to determine if the local site has the patient population, support staff, medical facilities, and equipment necessary to successfully carry out the study protocol.
Title I amends the Federal Food, Drug, and Cosmetic Act to include post-marketing safety activities in the review of drug application. This included developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems and conducting screenings of the Adverse Event Reporting System ...
The final analysis is the Post-Independent Analysis which reviews the previous three functional analyses and selects an approach or approaches that best close the capability gaps. The original proposal sponsor documents a recommended change or produces an Initial Capabilities Document for a system.
'Event identification': Internal and external events that affect the achievement of the objectives of an entity must be identified, distinguishing between risks and opportunities. The opportunities are re-channeled into management strategy or goal-setting processes.
The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. A manufacturer of medical devices is required to report incidents (serious adverse ...
An economic impact analysis (EIA) examines the effect of an event on the economy in a specified area, ranging from a single neighborhood to the entire globe. It usually measures changes in business revenue, business profits, personal wages, and/or jobs. The economic event analyzed can include implementation of a new policy or project, or may ...
The PDUFA date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). The PDUFA date may be extended by the Food and Drug Administration in certain circumstances. [6]
If the assessment is favourable, and the proposed policy is enacted—after a suitable length of time for the policy to gain traction—it might be followed by an impact evaluation; ideally, assessed impacts before the fact and evaluated impacts after the fact are not wildly divergent. In some cases, impact becomes politicized due to a change ...