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The Department of Justice (DOJ), HHS and the FTC have jointly launched a public-facing portal for reporting unfair and anticompetitive practices that the Biden administration says will support its efforts to lower healthcare and prescription drug costs. Read More
In this edition of Quick Notes, AstraZeneca nabs a new indication for a severe asthma drug, Alvotech and Teva win FDA approval for a Stelara biosimilar, Takeda secures approval for a maintenance therapy for Crohn’s disease, Lumicell’s drug-device imaging combination for breast cancer wins regulatory clearance, and Roche’s lung cancer adjuvant therapy snags an FDA nod. Read More
Stagnant liquid inside an air purification unit, hundreds of complaints on tablet counts and inadequate guidance to call centers are but a few of the litany of issues outlined in the FDA’s Form 483 levied on India-based Sun Pharmaceuticals. Read More
To detect, prevent and manage medicine shortages in the EU and European Economic Area (EEA), the European Medicines Agency (EMA) will create a new system to gather information about medicine supply and demand. Read More
This edition of Quick Notes looks at FDA clearances and classifications for devices involving cranial implants, Parkinson’s Disease symptoms, at-home blood sampling and robotic microsurgery. Read More
The fact that China manufactures almost all of the active pharmaceutical ingredients (API) used to make drugs for Americans could be a threat to national security, according to FDA Commissioner Robert Califf. Read More
The FDA’s CDRH 2024 safety and innovation reports tout how the center has updated its 2018 Medical Device Safety Action Plan and regulated evolving technologies while working to make the U.S. market more innovative for devicemakers. Read More
A second recall of Fresenius Kabi’s Ivenix Infusion System this year has been classified Class I by the FDA due to multiple potentially life-threatening anomalies caused by the device’s version 5.8.0 LVP software. Read More
The FDA Oncology Center of Excellence has announced Project Asha, an initiative in collaboration with the White House Cancer Moonshot Program to increase oncology clinical trial access in India. Read More
The European Medicines Agency (EMA) has released a document detailing how the agency’s real-world evidence (RWE) office can help with medical research. Read More