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Recommendations in the latest installment of the Prescription Drug User Fee Act (PDUFA) seek to bulk up the premarket drug approval process, stabilize financing and expedite drug development, FDA officials said at a public hearing last week.
STAAR Surgical has provided an update on the status of the firm’s submission to the FDA for approval of its Visian toric implantable Collamer lens (TICL) designed to treat myopia and astigmatism.
Encore Medical’s reworking of its Speedblock surgical instruments caused the premature failure and splitting in half of the devices during surgery, prompting a recall of the product, the FDA said in a recent warning letter.
The Massachusetts Medical Device Industry Council (MassMEDIC) announced the launch of its coaching program for Massachusetts medical device startup firms.
A series of studies comparing drug-eluting stents with bare-metal stents points to an emerging consensus that the longer the drug-eluting devices remain implanted, the greater chances are that patients will develop life-threatening blood clots (thromboses).
The FDA sent a warning letter to Levitronix for several current good manufacturing practice violations, including failure to review complaints and set quality standards.
The FDA’s proposal to regulate complex genetic laboratory-
developed tests (LDTs) could stifle the development and marketing of new diagnostics, presenters said at a recent public meeting.
Federal investigators from the FDA’s Office of Criminal Investigations unexpectedly showed up Feb. 14 to conduct a full-scale search of Ranbaxy offices and a manufacturing plant in New Jersey, company sources said.
The FDA has followed a joint advisory committee’s recommendations in removing two of three approved indications for Ketek and adding a black box warning to the antibiotic’s labeling.