Two stakeholders offer recommendations to clarify an FDA draft guidance on voluntary consensus standards relating to drug quality.
Immuron says it is planning to develop and seek FDA approval for IMM-124E, its bovine polyclonal antibody drug candidate for preventing travelers diar...
A Florida federal court denies an Apotex motion seeking to dismiss the latest Amgen patent suit over Apotex biosimilar Neupogen and Neulasta products....
Takara Bio files a Drug Master File to FDA for the liquid formulation of RetroNectin GMP grade.
FDA clears an Elucent Medical 510(k) for the EnVisio Surgical Navigation System to identify the location of the tissue to be removed.
Senate Finance Committee chairman Charles Grassley asks HHS for information on its implementation of recommendations made by the HHS Inspector General...
CDER staffers describe the Centers new Public Health Assessment via Structural Evaluation being used to characterize new opioids as part of FDAs work ...
FDA clears a Getinge 510(k) for a new software version for the Servo-u and Servo-n mechanical ventilator platform.