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.
Boise, Idaho-based Smart Surgical, which does business as Burst Biologics, failed to ensure that its blood products were free of the threat of infection and contamination, the FDA said in a warning letter to the company. Read More
The move follows a December injunction temporarily halting pay-for-delay agreements between branded drug manufacturers and makers of generics in the state. Read More
The FDA’s Office of Pharmaceutical Quality (OPQ) used alternative tools because of the ongoing pandemic that reduced the number of facilities needing pre-approval inspections by more than 50 percent in fiscal 2021, OPQ said in its annual report released yesterday. Read More
The European Medicines Agency (EMA) recommended 92 medicines for authorization by the European Commission in 2021, 53 of which had a new active substance that had not been authorized in the EU before. Read More
The approval comes after a phase 3 trial of 5,674 patients in which Kerendia resulted in lower risks of CKD progression and cardiovascular events. Read More
The European Medicines Regulatory Network announced yesterday that it has adopted a common standard for the electronic product information (ePI) on medicines in the EU. Read More
FDA’s Office of Prescription Drug Promotion (OPDP) has issued a warning letter to precision medicine developer CytoDyn about a video interview found on the company’s corporate website. Read More
The FDA has announced that it found four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the troubled Emergent BioSolutions manufacturing facility in Baltimore, Md., to be acceptable for use for potential export. Read More