The FDA intends to change the way it handles plant inspections, using metrics to suggest which plants may be having issues and making more frequent trips to those that appear at risk. While those companies committed to quality may be rewarded for their efforts, a new report warns that those that are already struggling with quality can expect to be more under the thumb of regulators.
Last month, senators pointed to problems with duodenoscopes linked to superbug outbreaks and partly blamed an outdated FDA reporting system for not adequately monitoring the devices' safety. The lawmakers want to give the system a facelift, but they could face obstacles from hospitals and Medicare officials who are railing against some of the proposed changes.
FDA staff reviewers were supportive of the Remicade biosimilar from Celltrion ahead of next week's advisory committee meeting. The reviewers said that the drug is "highly similar" to the branded product in terms of safety, purity and potency.
The FDA has been repeatedly criticized for expanding approvals for opioids in the face of an "epidemic" of abuse and overdoses. Today Dr. Robert Calif, President Obama's pick to head the agency, took that matter head-on, calling for a sweeping review of the agency's policies.
The pharma industry heralded 11 new blockbusters in 2015, an act that's tough to follow. But while 2016 may not see quite that many, it's still on track to ring in 7 new therapies that have a shot at cracking the billion-dollar sales mark, a new analysis says.
The FDA's promotional police plan to address social media links for pharma again this year. Maybe. That is, the issue is on the agency's annual agenda of "new and revised draft guidances CDER is planning to publish during calendar year 2016."
Mumbai-based drugmaker Wockhardt is once again in the crosshairs of the U.S. Food and Drug Administration (FDA) after the American regulator found the pharma giant was hiding the results from failed tests on drugs and deleting the resulting data from computer systems at a plant in western India, according to a report by Reuters.
AbbVie and Roche's venetoclax has received yet another accelerated review from the FDA--this time in patients with the most common type of acute leukemia.
Interoperability is an increasingly important component of med tech, due to the need for communication and data exchange within a networked system of other devices, electronic health records and clinicians. Poor interoperability is blamed for problems like "alarm fatigue" whereby poorly networked devices produce an excessive number of loud warnings out of an abundance of caution, leading to the risk that a necessary alarm will be ignored.
Thanks to an FDA decision over the weekend, Bristol-Myers Squibb's immunotherapy Opdivo has caught back up to Merck's Keytruda in melanoma. And it won a new combination approval from the FDA to boot.