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 ...
FDA issues a guidance on nonclinical information to support the development and approval of orally inhaled nicotine-containing drug products.
Four drug companies recommend technical changes to an FDA draft guidance on evaluating cancer drugs in patients with central nervous system metastases...
Federal Register notice: FDA makes available a final guidance entitled Necessary Automated External Defibrillator Accessories: Policy Regarding Compli...