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According to AdvaMed, an online medical device labeling database poses numerous problems, “including risk to patient safety due to the frequency at which patient labeling may be updated.” Read More
“A review of the claims and their intermixing dependencies presents an overall picture of a set of claims designed to preempt a conspicuously large number of different dosage regimens for a large variety of conditions using a long list of formulations, which is disconnected from a written description that is far more limited in its disclosure,” the ruling states. Read More
The entities would apply for the appropriate conformity assessment procedure and provide UDI-product registration, the Commission said in five newly released guidances that provide clarification on UDI provisions. Read More
As digital transformation sweeps through the pharmaceutical and medical device industries like a tsunami, stakeholders in those sectors are trying to figure out how to deal with the staggering changes that are likely to be left in its wake. Read More
The U.S. deadline for pharmaceutical manufacturers to implement item-level serialization as part of a global regulatory effort to stem product counterfeiting and diversion is less than a month away — a key step in a process designed to deliver a fully secured U.S. drug distribution system by the end of 2023. Read More