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.
The FDA warned investigational medical device sponsor UVLrx Therapeutics for failing to obtain required authorization from its Institutional Review Board. Read More
In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. Read More
The FDA finalized its guidance on developing direct-acting antivirals for chronic hepatitis C, outlining Phase III trial design options, enrollment criteria and safety evaluations for specific patient populations. Read More
The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement. Read More
The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations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
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
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
A major manufacturer of generic drugs in India failed to follow up as required on laboratory tests that showed its products at two facilities did not meet specifications, in some cases improperly dismissing the red-flag results, the FDA said in a warning letter. Read More