We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Sponsors of cancer drugs can apply for real-time review of their trial data if their investigational products demonstrate substantial improvements over available therapy and use straightforward study designs and endpoints that can be easily interpreted, according to a new FDA draft guidance. Read More
Biogen is writing off $275 million worth of Aduhelm (aducanumab) inventory — a formal declaration that the Alzheimer’s drug has no market value at all. Read More
In a pair of final guidances published Friday, the FDA outlined acceptable reasons for requesting an extension for responding to a Complete Response Letter (CRL) and provided answers to frequently asked questions about the Orange Book, the agency’s reference text for generic drug substitutions. Read More
It’s looking more and more likely that Congress will miss its deadline to pass a user-fee reauthorization bill — potentially forcing the agency into sending out furlough notices to its employees after Aug. 1. Read More
Countries participating in this year’s Pangea XV, an international illicit drug crackdown, made more than 7,800 seizures of illicit and misbranded medicines worth $11 million and totaling 3 million individual units. Read More
The FDA announced Friday that remote regulatory assessments (RRA) have proven to be a valuable tool and the agency will continue to use them beyond the COVID-19 pandemic. Read More
The FDA issued a proposed rule on Friday that would require drugmakers to use a standardized 12-digit National Drug Code (NDC) format with three distinct segments. Read More