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CMS’s decision to allow coverage of positron emission tomography (PET) agents used to detect amyloid plaque deposits in the brain means patients suspected of having Alzheimer’s may now be covered for more than one PET scan per lifetime, and need not be in a clinical trial to receive the scan. Read More
Understanding FDA quality system requirements may be more confusing under the new Quality Management System Regulation (QMSR) due to be finalized in December, says one regulatory expert, but actual compliance will be less cumbersome when U.S. and international expectations are aligned. Read More
Over the past week, the FDA issued final guidances on assessment of tissue containment systems, testing and labeling medical devices for safety in the magnetic resonance environment and draft guidance on quality considerations for topical ophthalmic drug products. Read More
Companies manufacturing drug-device combination products must determine whether the benefits associated with each constituent part and the overall product outweigh the risks, says Susan Neadle, president of Combination Products Consulting Services. Read More
The European Commission (EC) is requiring DNA sequencing company Illumina to unwind its acquisition of liquid biopsy company Grail, an action mirroring the FTC’s April order to do the same. Read More
A top benefit of the Case for Quality Voluntary Improvement Program (VIP) for medical devices — a collaborative initiative formally recognized by the FDA in recent weeks — is to give devicemakers a way to get the FDA’s help with quality measures that go beyond regulatory compliance. Read More
Abiomed received a warning letter for its Impella Connect System for failing to have an approved application for premarket approval or an investigational device exemption, according to the FDA’s warning letter. Read More
The FDA has created the new Digital Health Advisory Committee to help the agency explore the complex issues related to artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software as well as decentralized trials, patient-generated health data and cybersecurity. Read More
Guidance updates, Novo Nordisk complaint against semaglutide compounders tossed, and AdvaMed forms new digital tech division, in this edition of Quick Notes. Read More