Menaflex: The Winding Road To Rescission
This article was originally published in The Gray Sheet
Executive SummaryFDA announced on Oct. 14 that it plans to seek rescission of ReGen Biologics' 510(k) for the Menaflex collagen scaffold. The device has already experienced many twists and turns along the regulatory pathway, as this timeline suggests:
You may also be interested in...
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.
It has been a long and sometimes tortuous development path for Lupuzor but ImmuPharma's chief executive tells Scrip the company's faith in the lupus drug is bearing fruit.