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.
Australia’s the Therapeutic Goods Administration has fast-tracked the approval of new rapid tests for COVID-19, with 500,000 tests expected to become available in the county by the end of March. Read More
Inadequate corrective and preventive actions were a repeat observation that came up in an inspection of Keystone Manufacturing’s Kalamazoo, Michigan facility. Read More
Contract manufacturer Paragon Manufacturing of Everett, Washington had not established adequate procedures for acceptance of incoming products, and procedures were not in place to control product that did not conform to specifications, an FDA inspection revealed. Read More
President Trump invoked the Defense Production Act in response to the growing coronavirus pandemic, enabling the federal government to order private industry to manufacture emergency medical supplies. Read More
The FDA announced in a new guidance that it does not plan to object to delays in adverse event reporting for medical products during the pandemic. Read More
With the FDA’s foreign inspections on hold through April due to the coronavirus outbreak, the agency is doing “anything and everything” to make use of international regulators to keep inspections going, according to a senior agency official. Read More
The European Commission is seeking to push back the implementation date of the Medical Device Regulation (MDR) by one year as COVID-19 wreaks havoc globally. Read More
The FDA has authorized Roche’s cobas SARS-CoV-2 novel coronavirus diagnostic test for emergency use — the third emergency use authorization it has granted in its efforts to combat the outbreak. Read More
Failure to establish corrective and preventive actions procedures and systems for receiving, reviewing and evaluating complaints landed devicemaker Oxus a 483 following an inspection of its Auburn Hills, Michigan facility. Read More