Scope of the PIP in the EU: easier accessibility to the paediatric rewards and simplification of administrative requirements
This article was originally published in SRA
Executive Summary
The European Medicines Agency’s policy on changes in the scope of paediatric investigation plan decisions will make it easier for drug companies to reap the available rewards as well as cut down on the paperwork, insist Paolo Tomasi and Agnes Saint Raymond.
You may also be interested in...
Are Regulators Ready For The Robot Era? ChatGPT Weighs In On EU Regulation
Artificial intelligence model’s comments signal the likely start of computer-generated comments to the US FDA’s public notices.
Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings
Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.