Jun 6, 2022
Asia
The article provides an overview of Pakistan’s regulatory framework for clinical trials and applications to be submitted by interested parties. Table of Contents The Drug Regulatory Authority of Pakistan (DRAP), a country’s...
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Jun 5, 2022
Asia
The new article addresses specific aspects regarding the Essential Principles medical devices should comply with to be allowed for marketing and use in Singapore. In particular, the article describes in detail the general requirements to be followed, and also the...
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May 17, 2022
FDA
The new article highlights specific aspects related to the clinical studies and the way they should be undertaken to ensure the accuracy and reliability of the results, including the patient demographics, safety endpoints, and analysis. The document constitutes a...
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May 14, 2022
FDA
The article addresses the aspects related to the study duration, and also the inclusion/exclusion criteria to be considered. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other...
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May 9, 2022
FDA
The article provides an overview of the regulatory requirements for medical devices used to improve glycemic control. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties...
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