US FDA’s external advisors will meet May 18 to consider allowing use of central venous access lines in a study of two Duchenne muscular dystrophy drugs. Agency briefing documents show decision-making on placebo-controlled trial design was informed by problems in the clinical development of Exondys 51 (eteplirsen).
US FDA advisory committee deliberations over the potential allowance of central venous access lines in a Sarepta Therapeutics Inc. Duchenne muscular dystrophy drug trial could have broader implications for use of placebo-controlled trials and alternative study designs in rare disease populations.
In briefing documents released ahead of a May 18 meeting, FDA poses only one voting question for its...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.
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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it produces.
