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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
The European Medicines Agency is calling for public comment on the International Council for Harmonization (ICH) new draft guidance on conducting drug interaction studies. Read More