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Less than a week after the EMA issued a report on its adaptive pathway, a German agency is taking the agency to task for leaving stakeholders in the dark on real-world evidence use. Read More
The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
The FDA is tweaking its process for designating which center gets jurisdiction over products that defy easy categorization by offering companies a pre-review pathway. Read More
The EMA is mapping out trial designs for the development of therapies to treat Crohn’s disease, ulcerative colitis and mycobacterium tuberculosis. Read More
The fallout continues from a series of deaths in Juno Therapeutics’ leukemia trial, as the company disclosed that it experienced four patient deaths, not three as it had previously reported. Read More
The EMA is advising drugmakers to rely on two types of analyses — metabolic and mechanism of action — to determine the minimum effective dosage for antimicrobial drugs. Read More
An FDA advisory committee unanimously recommended the agency approve five indications for Amgen’s biosimilar of AbbVie’s blockbuster drug Humira. Read More