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The Supreme Court’s reversal of a 40-year-old precedent that had smoothed the regulatory agency pathway now makes it easier for courts to step in with their own interpretation of a law’s effect on regulatory issues. Read More
The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. 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of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1.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
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
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