The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
In a new enforcement initiative intended to boost drugmaker quality, the European Medicines Agency (EMA) has begun publishing the names of manufacturing facilities that fall out of compliance with good manufacturing practices (GMP). Read More
The FDA does not intend to prevent compounders from making preterm birth drug Makena (hydroxyprogesterone caproate), the agency stated in a legal filing last week that outlines how it intends to approach one contentious issue involving compounders. Read More
The FDA issued a Form 483 to Biogen Idec that cites a weakness in the way the company manages suppliers, highlighting the difficulties drugmakers continue to have with supplier quality issues. Read More
A group of pharmaceutical representatives has recommended 10 product and site quality metrics that the FDA should consider collecting from manufacturers, helping the agency shape its new quality metrics program. Read More
Beginning today, new safety and efficacy findings that emerge during postmarket clinical trials should be reported in periodic safety update reports (PSURs) submitted to the European Medicines Agency (EMA). Read More
A group of pharmaceutical representatives has recommended ten product and site quality metrics that the FDA should consider collecting from manufacturers, helping the agency shape its new quality metrics program. Read More
The European Medicines Agency has concluded a review of lax adverse event reporting at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. Read More