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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
Device manufacturers in India have until May 31 to get a certificate from the International Organization for Standardization (ISO) for their quality management systems. Read More
Selective laser therapy (SLT) is now the UK’s recommended initial treatment of choice for glaucoma, according to new treatment guidelines issued by the National Institute for Health and Care Excellence (NICE). Read More
The FDA has released new guidance that shares considerations for consulting with patient advisers to improve the conduct and design of medical device trials. Read More
The FDA has kicked off the new year with attention to medical device trials, issuing final guidance with detailed recommendations for using patient reported outcomes (PROs). Read More
The European Parliament has endorsed a plan to strengthen the powers of the European Medicines Agency (EMA) to increase monitoring of the supply chain for drugs and medical devices. Read More