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After an FDA advisory committee voted overwhelmingly against its ALS drug NurOwn, BrainStorm Cell Therapeutics announced that it is withdrawing the BLA for the drug so that it can conduct an additional phase 3 trial. Read More
The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall, as a potential leak could cause the machine to stop delivering air, which could lead to serious injury or death. Read More
The FDA smacked Samsung Biologics for using technology to support application submission testing that had inadequate data integrity controls, among other lapses, following an inspection of its Incheon, South Korea, facility conducted in August and September. Read More
It’s rare, but it turns out a company seeking approval for a new indication can find success in the wake of an FDA Complete Response Letter (CRL) as is the case for Ardelyx’s Xphozah (tenapanor). Read More
The FDA has issued a new final guidance intended to facilitate the development and assessment of regenerative medicine therapy (RMT) products CBER regulates through identifying and recognizing voluntary consensus standards (VCS). Read More
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 provisions in the Inflation Reduction Act (IRA) are unconstitutional. Read More
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. Read More
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. Read More
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 FDAnews, a WCG company, on what to expect from the FDA in 2024, quality culture and how to use UDI and UDI Data. Read More
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. Read More
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 Greg Williams, industry veteran and a quality assurance consultant based in Dallas-Ft. Worth. Read More
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 European Council (EC) does not have jurisdiction over the acquisition. Read More