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.
Delaware has become the latest state to let pharmacists substitute biosimilar products for the prescribed biological reference product, a move cheered by a national trade group representing biopharmaceutical manufacturers. Read More
The FDA has warned two more compounding pharmacies for actions that occurred prior to passage of a new federal law that boosted the agency’s authority over such facilities. Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for significant GMP deviations including failures to ensure adequate environmental monitoring and employee training. Read More
Massachusetts-based Fresenius Medical Care North America has issued two voluntary recalls of a concentrate used in dialysis machines over fears of bacterial contamination, the FDA said. Read More
The FDA chided positron emission tomography (PET) drug manufacturer IBA Molecular North America for not properly handling complaints and quality production. Read More
Sun Pharma is in the midst of another quality problem, this time involving a recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. 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 slammed biologic manufacturer Greer Laboratories in a warning letter for extensive quality problems, including the presence of pests in its manufacturing plant, and making unapproved allergenic extracts. Read More