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The FDA needs to work with the Federal Trade Commission (FTC) and other federal agencies to improve its regulation of at-home diagnostics, which are not clearly distinguished from relatively unregulated “general wellness products,” according to an opinion piece by three bioethicists in the Journal of the American Medical Association. Read More
The Center for Devices and Radiological Health (CDRH) has set aggressive goals to measure its success over the next few years in a “strategic priorities” report released yesterday. Read More
Becton Dickinson (BD) has completed its purchase of Cytognos, a privately held Spanish company that specializes in flow cytometry products for blood cancers. Read More
Senators and members of the House of Representatives from both political parties have asked the FDA to explain the holdup in submitting the commitment letter that the agency negotiates with the industry ahead of reauthorization of the Medical Device User Fee Act (MDUFA). Read More
New guidance from the European Union on implementing the In Vitro Diagnostics Regulation (IVDR) emphasizes that regulators will expect to see continuous evidence of a diagnostic product’s safety throughout its entire lifecycle. Read More
Chinese authorities have arrested AstraZeneca China employees who are accused of tampering with gene-testing results of tumor patients in order to fraudulently claim reimbursement from national health care insurance funds. Read More
The FDA’s proposed rule on over-the-counter (OTC) hearing aids has attracted more than a thousand public comments, some supportive of the proposal and some opposed to permitting marketing of hearing aids without a prescription. Read More
The EU’s Clinical Trials Regulation (CTR) comes into effect today and harmonizes submissions, data assessment and supervision processes for trials across the EU and in the three European Economic Area (EEA) countries — Iceland, Liechtenstein and Norway. Read More