A year after the European Medicines Agency announced plans to publicly disclose the key elements of pediatric investigation plans to make its regulatory decisions more transparent, concerns around confidentiality issues and resources means no final decision has yet been made on the implementation of this controversial proposal.
The European Medicines Agency has put on hold its controversial proposal to publicly disclose more details from pediatric investigation plans (PIPs) submitted by companies under the EU Paediatric Regulation, following concerns about the disclosure of commercially confidential information and because of issues relating to resources.
The EMA had originally said it would start publishing the key elements of a PIP decision early this year. The...
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
