The FDA is seeking public comment on a proposed template for the submission of electronic data to the agency from clinical trials. 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

The FDA is seeking public comment on a proposed template for the submission of electronic data to the agency from clinical trials. Read More

The FDA has issued warning letters to two clinical investigators who deviated from their investigational plans. Read More

The FDA has taken two clinical investigators to task for deviating from their investigational plans. Read More

Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More

French drug giant Sanofi will spend $245 million to acquire San Diego-based Retrophin’s rare pediatric disease priority review voucher. Read More

The European Medicines Agency has confirmed plans to halt sales of 700 drug forms and strengths authorized based on clinical studies performed by Hyderabad, India-based GVK Biosciences. Read More

Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, the Chinese regulators say. Read More

The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More

New guidance on extrapolating existing data to gain approval for pediatric indications applies to new devices as well as those already approved for adult use, an FDA official says. Read More