This edition of interesting device approvals and clearances includes a pulsed field ablation system, a transesophageal echocardiography ultrasound transducer, a digital cytology system that combines deep-learning-based AI, and a deep…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has proposed waiving certain requirements for biosimilars on “solid” evidence of quality comparability. Source: Drug Industry Daily
Vanda Pharmaceuticals is once again suing HHS and the FDA, claiming that the agencies are using regulatory process to accomplish an “end run” around the timetable required by law in…
The FDA’s Office of Clinical Pharmacology (OCP) conducted more than 5,600 reviews of investigational new drug (IND) submissions in 2023, helping determine correct dosing for 55 new drugs and biological…
The Federal Trade Commission (FTC) has waded into the march-in rights fracas, supporting the obscure Bayh-Dole Act as a tool to moderate drug pricing and control patent thickets on drugs…
Rather than trying to predict which medical devices could be in short supply during a national emergency, the FDA should focus on identifying those that are “mission critical” to patient…
Percussionaire’s recall of High-Frequency Transport Phasitron Breathing Circuit kits has been identified as a Class I recall by FDA due to a product defect that causes over-pressurization. Source: Drug Industry…
The FDA did not attend a House Energy and Commerce subcommittee hearing Tuesday focused on why the agency has stalled out on its pre-pandemic efforts to improve inspections of overseas…
An analysis of 10 FDA approved drug-device combinations containing GLP-1 receptor agonists found that the patents for the device portion made no mention of active drug ingredients — a requirement…
The FDA has finalized its 2021 draft version of a guidance that describes the timing and process of annual reporting of manufactured drugs, an effort intended to enhance the FDA’s…