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Jul 112 min read

EU Guidance: Procedural Advice on Paediatric Applications

The European Medicines Agency (EMA) provides detailed guidance "Procedural Advice on Paediatric Applications" that aims to facilitate the...

Jun 52 min read

EMA Guidance: Procedural Advice on Paediatric Applications

The European Medicines Agency (EMA) yesterday(04 June 2024) updated and released the guidance document "Procedural Advice on Paediatric...

Jan 131 min read

EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations

Developing drugs specifically for paediatric use comes with its own set of challenges, including ethical considerations, appropriate...

Jun 17, 20231 min read

EMA Guidance: Paediatric Submissions Via Syncplicity Web Client

Recently on 09 June 2023, the European Medicines Agency released updated guidance on "Paediatric Submissions Via Syncplicity Web Client"....

May 18, 20232 min read

USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations

The United States Food & Drug Administration released two draft guidelines today (18-May-2023) "Pediatric Drug Development: Regulatory...

Sep 8, 20221 min read

USFDA Guidance: Clinical Pharmacology Considerations for Pediatric Studies of Drugs & Biologics

Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology...

Apr 10, 20222 min read

ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study

As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...

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...