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.
Lawyers and consumer groups are breathing down Johnson & Johnson’s (J&J) neck following a warning issued by the company and the FDA last week that its contraceptive patch Ortho Evra may put patients at risk for blood clots and other serious side-effects.
Diagnostics firm R2 Technology has renewed a three-year agreement with group purchasing organization Consorta to distribute R2’s ImageChecker computer-aided detection (CAD) technology for the early detection of breast cancer and other medical conditions.
Sharps injury prevention features on medical devices should be easily discernible to the user, and, once activated, should remain protective through disposal of the device, according to a new guidance that stresses design controls as a way to prevent needle-stick injuries.
After some lengthy delays, the FDA this month will require drugmakers to adopt the structured product labeling (SPL) format for certain human drug labeling submissions, an agency official said.
The XML-based structured product labeling (SPL) format for human drug labeling content will provide benefits beyond compliance with FDA electronic submission mandates, an industry expert said.
The FDA has warned physicians to stop using Boston Scientific’s injectable polymer Enteryx because of the risk of serious adverse events, including death.
Determining what is advertising and what is labeling on a device firm's corporate website can be difficult, says an FDA official who describes the ambiguity as "one of the biggest issues" the agency faces regarding the internet.
Switching to the structured product labeling (SPL) format for labeling content submissions will require pharmaceutical manufacturers to make some adjustments in their IT infrastructures, experts said.
Beginning at the end of the month, the FDA will require drugmakers to adopt the structured product language (SPL) format for certain human drug labeling submissions, according to an agency official.