Federal Register notice: FDA announces an 11/19 virtual public meeting on reauthorizing the Biosimilar User Fee Act program.
Federal Register notice: FDA makes available a final guidance on inhaled nicotine product nonclinical testing.
FDA says Baxter is reminding customers that deviations from prescribed cleaning methods for Sigma Spectrum infusion pumps could hurt pump functionalit...
CDER analyzes factors that contribute to an increased likelihood of ANDA submissions for NCE and non-NCE innovator drugs.
FDA pitches a plan to enhance its Model-Informed Drug Development (MIDD) activities under the next iteration of its Prescription Drug User Fee Act pro...
FDA signs a five-year agreement with SomaLogic to study using proteomics to identify biomarkers that may be useful in demonstrating biosimilarity of a...
CDRH seeks a boost to its resources as it negotiates the reauthorization of the Medical Device User Fee Act (MDUFA) program, claiming Covid-19 is taki...
The Justice Department asks a California federal court for an injunction to prevent Med-Pharmx from manufacturing and distributing adulterated animal ...