Regulatory Blog

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Dec 31, 20212 min read

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Hi Guys! You have been my supporters and wellwishers from the day I published this website. As you have been supportive of me from day...

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First Oral Antiviral (PFIZER) for Treatment of COVID-19 -USFDA

Sharan Murugan

Dec 23, 20212 min read

First Oral Antiviral (PFIZER) for Treatment of COVID-19 -USFDA

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

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Updated Guidance for Priority Review ofProduct Registration - Saudi Food & Drug Authority

Sharan Murugan

Dec 21, 20211 min read

Updated Guidance for Priority Review ofProduct Registration - Saudi Food & Drug Authority

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

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Updated Guidance on Innovative Licensing and Access Pathway - MHRA

Sharan Murugan

Dec 21, 20211 min read

Updated Guidance on Innovative Licensing and Access Pathway - MHRA

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

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Guidance for Residual Solvents: Q3C(R8) Impurities

Sharan Murugan

Dec 18, 20212 min read

Guidance for Residual Solvents: Q3C(R8) Impurities

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

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CMC Post Approval Manufacturing Changes for Specified BLA - in Annual Reports USFDA

Sharan Murugan

Dec 18, 20211 min read

CMC Post Approval Manufacturing Changes for Specified BLA - in Annual Reports USFDA

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

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USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions

Sharan Murugan

Dec 11, 20211 min read

USFDA draft guidance on : Cover Letter for Controlled Correspondences & ANDA Submissions

On December 10, 2021, the FDA published the draft guidance for industry entitled “Cover Letter Attachments for Controlled Correspondences...

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Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making

Sharan Murugan

Dec 11, 20212 min read

Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making

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

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Updated Version of Clinical Outcome Assessment Compendium -USFDA

Sharan Murugan

Dec 11, 20211 min read

Updated Version of Clinical Outcome Assessment Compendium -USFDA

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

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Parallel Imports of Human Medicines– Ireland HPRA

Sharan Murugan

Dec 7, 20212 min read

Parallel Imports of Human Medicines– Ireland HPRA

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

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Regulations & Requirements for Conducting Clinical Trials – SFDA

Sharan Murugan

Dec 7, 20211 min read

Regulations & Requirements for Conducting Clinical Trials – SFDA

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

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USFDA publishes FY 2022 GDUFA Science & Research Priority Initiatives & FY 2022 collaboration

Sharan Murugan

Dec 5, 20211 min read

USFDA publishes FY 2022 GDUFA Science & Research Priority Initiatives & FY 2022 collaboration

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

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