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What is postmarketing report?

Abstract. Postmarketing drug surveillance refers to the monitoring of drugs once they docHub the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time.

What is an example of post-marketing surveillance?

Postmarketing Surveillance Drug Development. Dietary Supplement. Adverse Drug Reaction. Clinical Trial. Pharmacovigilance. Ensure. Infection. Side Effect.

What is the timeline for expedited safety reporting?

Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed as soon as possible but no later than 15 calendar days after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting.

What are post-marketing reports?

Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.

What is the difference between a PMR and a PMC?

PMRs are studies and clinical trials that sponsors are required to conduct under one or more statutes or regulations, and PMCs are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statute or regulation.

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