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The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations and the agency’s current thinking on extrapolating data in pediatrics. Read More
An FDA advisory committee voted 10-0 in favor of the efficacy of a drug candidate for treatment of glaucoma and ocular hypertension based on data from efficacy trials. Read More
Developers of antiviral drugs for prophylaxis and treatment of respiratory syncytial virus should expose at least 100 adults in clinical trials ahead of pediatric studies, the FDA said in new guidance for drugmakers. Read More
The Association of Clinical Research Organizations warned that the state of New Jersey’s plan to cap drugmaker payments to doctors could hurt clinical trials. Read More
Because of delays in implementing the EU regulation, the UK’s compliance with future EU clinical trials rules will likely be subject to negotiation, as the country plans to only immediately implement EU regulations that were in place ahead of the planned March 2019 exit from the EU, according to a UK government official. Read More
The European Medicines Agency outlined its thoughts on the use of evidence generated through clinical extrapolation techniques in regulatory assessments, in a draft reflection paper. Read More
New medical device clinical trial guidance aims to improve participation diversity and increase data consistency and transparency, FDA officials said in an Oct. 31 webinar. Read More
Most life sciences companies plan to significantly step up their use of real-world data sources over the next three years, according to a new survey by the Tufts Center for the Study of Drug Development. Read More
The White House’s Office of Management and Budget (OMB) proposes to delay for one year, until January 2019, the effective date of a revision to the sweeping Common Rule that governs federal policy on the use of human subjects in clinical trials. Read More
The European Medicines Agency is considering a draft addendum developed by the International Conference on Harmonization for the ICH’s 1998 clinical trial statistics guideline. Read More
An FDA advisory committee voted 10 to 1 that a muscular dystrophy drug candidate does not have enough supporting data to be considered effective, noting problems with interpreting data from clinical trials. Read More