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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
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
Sponsors of research into cell therapies should conduct preclinical studies either in vitro or in animals to address potential risks and methods of delivery before initiating investigations into the use of the products, according to new recommendations from Health Canada. Read More
The FDA has clarified what types of drug development topics it will accept for a critical path innovation meeting (CPIM), stressing again that the agency won’t give advice on individual submissions during a CPIM. Read More
Drugmakers seeking accelerated approval of a presurgical treatment for high-risk, early-stage breast cancer may consider conducting multiple trials rather than a traditional single trial, according to a new FDA guidance that aims to give sponsors an earlier indication as to the success of a drug candidate. Read More
Drug sponsors submitting plans to test products in children in Europe need to provide the European Medicines Agency with information on all formulations they are developing, according to a finalized pediatric investigation plan that took effect this week. Read More
The FDA has issued guidance on using social media for approved products, but the agency has been markedly silent on how drugmakers can use Facebook, Twitter and other platforms for drug development, an expert said. Read More
Clinical studies to evaluate drugs treating irritable bowel syndrome (IBS) should involve patients experiencing recurrent abdominal pain or discomfort at least three days per month in the previous 90 days, according to new final guidance issued by the European Medicines Agency. Read More