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.
Manufacturers of biosimilars need to demonstrate exactly how their products compare with the reference drugs as they design clinical trials, including by paying particular attention to assessments of exposure and effects of the product on the body, according to new FDA draft guidance on creating versions of the complex therapies. Read More
Proposed copyright requirements in a recent draft of the European Medicines Agency’s clinical trial data transparency policy run counter to EMA’s moves toward greater openness, researchers argue. Read More
House lawmakers want to give the FDA a $23 million increase in discretionary funds next fiscal year, but would restrict access to certain funds in a bid to prod the agency to finalize guidance on abuse-deterrent properties for opioids. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
Canadian drug regulators have temporarily banned Biolyse Pharma from making and selling its cancer-fighting agent paclitaxel after a series of inspections at the firm’s St. Catharines, Ontario, facility uncovered serious manufacturing problems. Read More
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official said. Read More
Injectable drug maker Hospira has issued a voluntary recall of dobutamine injection, USP, after a customer complaint of discoloration in a single vial of the heart disease drug. Read More
The FDA’s proposal to give generic manufacturers the same labelling authority as brand manufacturers is nothing short of “illegal,” argue two prominent FDA observers. Read More