The European Medicines Agency’s plan to publish details of the studies and measures it agrees with a drug developer for a pediatric investigation plan will help other companies in framing their future marketing authorization applications. But there are concerns that the agency's plan might result in the disclosure of commercially confidential information.
The European Medicines Agency is planning to make public the key elements in the pediatric investigation plans or PIPs that pharmaceutical companies have to submit under the EU Paediatric Regulation as part of its drive for more transparency and so that the information can be used by other drug developers.
The initiative, which is expected to get underway in early 2017, is expected to improve transparency by the agency. But...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
