CDER executives say that GDUFA reauthorization helps public health by providing funds for the Centers work to bring generic drugs to market more quick...
FDA clears a DePuy Synthes 510(k) for its recently launched Maxframe Multi-Axial Correction System, an external circular fixation device used to gradu...
FDA releases its latest batch of Warning Letters that includes Diasol and Kelyniam Global.
The International Council for Harmonization announces approval of two guidances and a question-and-answer document.
Teva Pharmaceutical Industries files a BLA for fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for preventing migraine heada...
Three attorneys look at the FTCs expanded efforts to regulate the line between permitted and potentially anticompetitive conduct by drug companies.
A Kentucky federal court dismisses a suit against Zydus raising seven allegations about the companys generic form of Cordarone.
Federal Register notice: FDA classifies enzyme packed cartridges into Class 2 (special controls).