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The FDA has approved Verona Pharma’s Ohtuvayre (ensifentrine), the first inhaled maintenance chronic obstructive pulmonary disease (COPD) drug in more than two decades, and granted marketing authorization of a novel in-office hepatitis C virus (HCV) test that will allow clinicians to receive rapid results and address the issue in one visit. Read More
Assuring the consistent performance of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1. Read More
This week, the FDA published a final guidance for small businesses on LDTs. The long-awaited draft guidance on diversity in clinical trials was also published. The agency modified its list of recognized standards and is seeking comments on its IT and customer experience strategies. Read More
Several Philips BiPAP devices and certain Baxter Life2000 ventilator systems are under FDA Class I recalls, the most serious type of recall, as use of the devices can result in serious injury or death. Read More
Identifying disease biomarkers in rural and medically underserved populations through breath-based diagnostics devices is the goal of the FDA’s partnership with the Bill & Melinda Gates Foundation, CDRH announced Wednesday. Read More
In this edition of Quick Notes EU, we take a peek at new advice regarding phthalates in medical devices, advice for drugmakers facing shortage woes and Finland’s worry over the deadly side effects of a painkiller. Also, when is an orphan device an orphan? Read More
The FDA is seeking comments on both its information technology (IT) and its customer experience strategies to guide its work and its allocation of budget and resources in the coming year. Read More
With FDA’s new regulation of laboratory developed tests (LDT) that becomes effective July 5, the agency has issued a final guidance intended to help small entities comply. Read More