Regulatory Blog

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Yesterday U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and...

Priority Review indicates that the review process of the application will be expedited by the concerned departments. However, the...

This new pathway supports innovative approaches to the safe, timely, and efficient development of medicines to improve patient access....

This guidance was developed within the Expert Working Group (Quality) of the International Council for Harmonisation of Technical...

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...

On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences...

Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of...

The COA Compendium is part of the FDA’s efforts to foster patient-focused drug development. The COA Compendium is intended to facilitate...

Parallel importation “The importation from an EU Member State, or an EEA country, of a medicinal product which is equivalent to one...

Saudi Food & Drug Authority released updated guidance on Regulations and Requirements for Conducting Clinical Trials in regards to “Early...

On December 2,2021 the U.S. (FDA) published the Fiscal Year (FY) 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research...