Pros and Cons of FDA's Medical Device Reporting rule
This article was originally published in Clinica
The final US Medical Device Reporting rule "imposes considerable burdens on domestic and foreign manufacturers for which civil and criminal penalties will be pursued", warns Medical Device Manufacturers Association (MDMA) counsel Larry Pilot. Although the final rule provides manufacturers with more time and some greater flexibility to determine what is subject to a report, the FDA estimates that the number of reports will increase by 50% to 150,000. "This alone suggests a significantly greater burden and liability for company personnel, in particular executives."
You may also be interested in...
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
The Swiss giant is hoping to get seven more approvals for its blockbuster immunology drug over the next 10 years.
Cadila has filed for approval of saroglitazar for NASH in India. The drug, which could emerge as the first medicine for the indication if approved, is already being used by a million Indian patients for diabetic dyslipidemia and hypertriglyceridemia.