FDA posts an International Council for Harmonization guidance E18 Genomic Sampling and Management of Genomic Data.
FDA chooses Booz Allen Hamilton for part of a seven-year $300 million blanket purchase agreement to support implementation of an informatics platform ...
CBER researchers say they are closer to understanding how to accurately interpret studies using microfluidics platforms so they can support developmen...
Federal Register notice: FDA reopens a docket for public comment on the susceptibility test interpretive criteria for antibacterial and antifungal dru...
FDA accepts for review a Pain Therapeutics NDA resubmission for Remoxy ER (oxycodone capsules), indicated for treating severe pain.
FDA extends the PDUFA review target date for Allergans Ulipristal.
FDA confirms that four more EU countries can conduct GMP inspections at a level equivalent to those conducted by FDA.
Mylan and Revance Therapeutics enter into a collaboration to develop a proposed biosimilar to Botox (onabotulinumtoxinA).