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.
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
Pfizer subsidiary Meridian Medical Technologies is under continued pressure from the FDA to improve oversight and quality at its Missouri plants. Read More
As more critics of the FDA’s approval of the painkiller Zohydro ER come forward, the agency says it will not limit approval of new opioid painkillers to those with abuse-deterrent properties. Read More
A group of generic drugmakers is proposing the FDA take the lead on initiating drug labeling changes prompted by adverse events, rather than relying on individual companies to initiate the changes. 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
U.S. President Barack Obama Nov. 27 signed into law a bill establishing both a nationwide track-and-trace requirement for prescription drugs and a system of voluntary U.S. Food and Drug Administration oversight of compounding pharmacies. Read More
The European Medicines Agency has launched a collaborative five-year program with the goal of developing a blueprint for a pan-European framework for monitoring the benefits and risks of vaccines throughout their lifecycles. 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
The European Commission is threatening to take legal action against four EU member states for failing to implement the Falsified Medicines Directive, an EU-wide anticounterfeit initiative that took effect in January. Read More
Drugmakers are pushing back against an Australian draft guidance on batch release protocols, asking the Therapeutic Goods Administration to allow authorized persons without access to the complete marketing application to release batches of a drug. Read More
Drugmakers and the FDA have different ideas about the proper scale for the agency’s quality metrics program. While industry supports collecting data on no more than four metrics, the FDA promises only that it will monitor no more than 16. Read More
OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says. Read More