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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...

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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...

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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...

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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"....

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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...

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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...

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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...

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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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