In a court filing earlier this week, Department of Justice (DOJ) lawyers assailed lawsuits from Bristol Myers Squibb (BMS) and Johnson & Johnson (J&J) that allege the drug price negotiation…
Seeking to better understand innovative clinical trial designs and approaches, CDER has asked stakeholders to share feedback on current barriers and opportunities around this topic. Source: Drug Industry Daily
Taking effect immediately is a guidance on non-invasive remote monitoring devices that gather patient physiological data from afar, reducing the need for in-office or in-hospital services. Source: Drug Industry Daily
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from…
The FDA provides clarity for drugmakers in a final guidance on how the agency’s considerations about a drug’s risks and benefits factor into NDA and BLA premarket and postmarket decisions.…
Though it might seem counterintuitive given the complex regulations and procedures required of the drug and device development industries, the real key to better quality lies in simplifying operations, said…
Illumina has already begun preparing for the divestment of Grail, although the company has already filed a challenge against the order with the European Court of Justice, claiming that the…
The FDA handed out a fistful of approvals this week, including three for Merck’s juggernaut PD-1 blocker Keytruda, bringing the drug’s total indications to 36. Source: Drug Industry Daily
Novo Nordisk will pay KBP Biosciences up to $1.3 billion to acquire ocedurenone, a drug for uncontrolled hypertension with potential applications in cardiovascular and kidney disease, the companies announced on…
A critical component of any strong quality management system (QMS) for manufacturing FDA-regulated medical products is the presence of a structured approach to investigating root causes of product and process…