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.
Regulators in Europe have proposed restricting access to certain information in a forthcoming clinical trials portal and database, but industry wants assurances that the system will be able to differentiate security access for different types of documents. Read More
Drugmakers in Europe are calling for the establishment of a new clinical trial portal and database, rather than modifying existing systems, to meet requirements for a single, streamlined submission process for clinical trial applications. Read More
Drug sponsors should find a more comprehensive way of recording and integrating patient outcomes data into their efficacy analyses, says a top FDA official who notes the lack of such data often presents a roadblock to making regulatory decisions. Read More
Researchers looking to study the safety and effectiveness of medical devices should tailor their trials to the requirements of the specific technology, a report by the Dutch Royal Academy of Sciences concludes. Read More
Clinical trial sponsors are increasingly looking to optimized trial design methods to simplify their studies and increase efficiency, but obstacles still stand in the way, an expert says. Read More
An article published in last month’s Journal of the American Medical Association is casting doubt on the idea that the scientific community and the general public should trust clinical trial results. Read More
Sponsors of novel drug therapies can evaluate their candidates against competing products in the UK without the threat of litigation, thanks to amended patent law that took effect Oct. 2. Read More
Sponsors say an FDA plan to require informed consent documents to include detailed descriptions of treatment alternatives to experimental drugs could confuse patients such that recruiting clinical trial subjects will be nearly impossible, drugmakers argue. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
Sponsors submitting plans to test drug products in children in Europe need to provide the European Medicines Agency with information on all formulations being developed, according to final guidance published Sept. 27. Read More
Starting Jan. 1, drugmakers that sell products in the EU will have to make publicly available clinical trial data used to support marketing authorization. Read More