Medical device evaluation can only be as effective as the tools used to conduct the evaluation. The FDA has begun seeking applications for the Medical Device Development Tools Pilot Program to validate and review such tools in preparation for a final guidance on the topic.
India's Central Drugs Standard Control Organization has issued new guidelines for state inspectors on how to prepare for and handle inspections of drug manufacturing facilities, Regulatory Focus points out.
With two Indian plants on the FDA import alert list and a U.S. facility recently written up, India's Wockhardt reported this week that its April-June net profit was off 94% compared to the same quarter a year ago, producing 199.5 million rupees ($3.26 million), down from 3.23 billion rupees ($52.9 million) a year earlier.
Until very recently, no serious consequences had been dealt out by India's Central Drugs Standard Control Organization (CDSCO), even for Ranbaxy Laboratories, which last year pled guilty to criminal charges in the U.S. for selling subpar drugs. But CDSCO appears to be turning over a new leaf--at least a little.
Expectations are high for the recently FDA-approved, donated lung preservation device, XVIVO Perfusion System with STEEN Solution.
The number of recalls overseen by the FDA has surged over the past two years, Regulatory Focus reports.
When the FDA issued a Form 483 to Ipca Laboratories late last month, the Indian API manufacturer voluntarily suspended shipments to the U.S. Now the release of details about the 483 has shown why Ipca acted swiftly, with the company joining the list of Indian drugmakers accused of data falsification.
Shares of Tekmira got a boost Thursday night after the company spread the word that the FDA had switched its full clinical hold on an experimental Ebola drug to a partial hold, clearing the path to its possible use to fight a sudden outbreak in Africa that has been sparking chilling headlines the world over.
Having racked up several warning letters over the past few years, Fresenius Kabi is now optimistic that two of its affected plants are getting back on track. Further progress is dependent on FDA inspectors visiting the plants in Grand Island, NY, and Kalyani, India, but with the agency dealing with failings at multiple companies, Fresenius thinks it might be a while before the regulator visits.
The FDA's decision to pursue broad, risk-based regulatory oversight for genetic and other laboratory-developed tests is drawing cautious, diplomatic and hopeful responses from industry.