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As the coming year approaches, EU regulators and pharma are ratcheting up their arguments for and against a plan to make more patient-level clinical trial data publicly available, beginning Jan. 1. Read More
When adding a pediatric indication to a drug product, drugmakers are advised to consider a range of different pharmaceutical forms and formulations that might be more suitable for children, a draft revision to European Commission guidelines on pediatric investigation plans says. Read More
Use of the “multiple comparison procedure – modeling,” or MCP-Mod, approach to dose response testing and estimation provides a “more solid basis” for Phase III dose selection, the European Medicines Agency says in a recently posted draft opinion on the methodology. Read More
While the FDA generally requires two Phase III trials to support approval of drugs to treat acute bacterial skin and skin structure infections (ABSSSI), an Oct. 16 final guidance says a single Phase III study that is supported by additional independent evidence may suffice. Read More
If EU regulators and pharma cannot agree on how to handle publication of clinical trial data, drugmakers may delay filing applications in Europe to preserve exclusivity, a Pfizer official says. Read More
Starting Sept. 30, sponsors in the UK must register their clinical trials on a publicly accessible database in order for them to be approved by the Health Research Authority. Read More
Researchers writing in the New England Journal of Medicine are calling for a more risk-based approach to regulating clinical trials and changes to regulatory systems, with the aim of removing unnecessary hurdles to medical research. Read More
The FDA is leaning on sponsors to convert from paper to electronic capture of clinical trial source data, saying the change should help eliminate unnecessary duplication of data and transcription errors and promote real-time access to data for review. Read More
As drug sponsors make their way through the EU approval process, there are “triggers” that can help European Medicines Agency inspection coordinators determine whether a clinical trial should undergo a routine or for-cause good clinical practice inspection, an agency working group says. Determining factors include trial size, complexity and site selection. Read More
Investigators contemplating their own clinical trials need to understand the regulatory framework of investigator-initiated studies and what it means to be a sponsor investigator before wading into the water, a legal expert says. Read More
More and more pivotal clinical trials — typically Phase III studies — submitted in support of drug applications in Europe are being conducted outside of the region, a new report by the European Medicines Agency (EMA) finds. Read More