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Overall reports of adverse events declined over the past three years from 21,729 in 2011 to 14,819 in 2013, according to data published by the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The Therapeutic Goods Administration is updating its guidance on the collection, maintenance and disclosure of commercially confident information, focusing on eight principles agency staff should consider in disclosing submitted information. Read More
The U.S. Food and Drug Administration may approve devices whose benefit-to-risk ratio is less certain if that uncertainty is “sufficiently balanced” by factors such as postmarket controls, the agency says in an April 23 draft guidance. Read More
The U.S. Food and Drug Administration is proposing a new, voluntary program to speed the approval of devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Read More
Physicians are calling on the European Parliament and the Council of the European Union to relax genetic counseling requirements in the In Vitro Diagnostic Device Regulation, saying they will restrict patients’ right to essential testing. Read More
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More
The South Korean government is proposing strict quality controls to ensure the safety of unregistered devices distributed during public health emergencies. Read More
Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than a related House bill. Read More