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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
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
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. Read More
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 Monday. Read More
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 shortcomings, and then taking action to address the root cause(s) through the corrective and preventive action (CAPA) process. Read More