Search


EMA Guidance: Procedural Advice on Paediatric Applications
The European Medicines Agency (EMA) has issued updated guidance " Procedural advice on Paediatric Applications " to support stakeholders...

Sharan Murugan
Apr 183 min read
7 views
0 comments


Latest ICH Guidance updates: M15-Model-Informed Drug Development, E6(R3)-Good Clinical Practice: Annex 2, & E11A -Pediatric Extrapolation
The International Council for Harmonisation (ICH) continues to advance global standards in drug development and clinical practices with...

Sharan Murugan
Dec 28, 20242 min read
28 views
0 comments


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...

Sharan Murugan
Jul 11, 20242 min read
44 views
0 comments


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...

Sharan Murugan
Jun 5, 20242 min read
65 views
0 comments


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...

Sharan Murugan
Jan 13, 20241 min read
95 views
0 comments


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"....

Sharan Murugan
Jun 17, 20231 min read
69 views
0 comments


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...

Sharan Murugan
May 18, 20232 min read
25 views
0 comments


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...

Sharan Murugan
Sep 8, 20221 min read
7 views
0 comments


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...

Sharan Murugan
Apr 10, 20222 min read
13 views
0 comments


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...

Sharan Murugan
Dec 18, 20211 min read
27 views
0 comments