FDA expands millennium bug database
This article was originally published in Clinica
The US FDA plans to expand the range of product information on its year 2000 website during the early part of 1999. Dr Bruce Burlington, director of the FDA's Center for Devices and Radiological Health, wrote to manufacturers of biomedical equipment on January 13 alerting them to the need for more detailed information on whether their products could have year 2000 compliance problems.
You may also be interested in...
Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.
Results of Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia “should prompt reconsideration of [OTC] mixed omega-3 fatty acid products for [atherosclerotic cardiovascular disease] prevention,” say cardiologists in an editorial published with JAMA study.
In a final guidance from the US agency, regulators say most combination product questions are best resolved through traditional pathways and noted that initiating a so-called combination product agreement meeting may be unproductive.