We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A year after the first approval of a treatment for female sexual desire disorders, the FDA has released draft guidance for drugmakers looking to develop the next female Viagra. Read More
The European Medicines Agency has begun publishing clinical study data for all new drug applications submitted after Jan. 1, 2015, regardless of approval status. Read More
The FDA’s draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments. Read More
Sponsors should conduct at least two randomized, double-blinded, controlled trials to establish efficacy and safety in trials for treating head lice infestations in children, the agency said in a final guidance. Read More
The International Council for Harmonisation identified the key scientific issues facing drug developers in pediatric indications in a draft updating its 16-year-old E11 guideline. Read More
With just over a month until new FDA regulations take effect mandating that all electronically submitted application data conform to a standardized format, the organization responsible for setting those standards is working to train industry to meet the requirements and is considering developing more frequent and granular updates to those standards in the future. Read More
Future cancer immunotherapy trials need new standardized endpoints and evaluation criteria, regulators and scientists said at an FDA workshop. Read More
The FDA is recommending that sponsors submit more detailed race and ethnicity data with their applications, compared to recommendations from a previous international harmonization guideline. Read More
A joint meeting of three FDA advisory committees tackled the issue of prescribing opioid painkillers in pediatrics and came up with a constant refrain: We need more data. Read More
Diabetes drugs carry special development challenges and can be the riskiest sector in pharmaceuticals, with one in 13 investigational drugs achieving U.S. approval, according to a report from the Tufts Center for the Study of Drug Development. Read More