Federal Register notice: FDA makes available a draft guidance entitled Pediatric Rare Diseases A Collaborative Approach for Drug Development Using Ga...
FDA asks Primus Pharmaceuticals (Scottsdale, AZ) to recall Limbrel, a capsule marketed to manage the metabolic processes associated with osteoarthriti...
CDER Office of New Drugs deputy director Peter Stein says the backlog of post-marketing requirements and commitments has been drastically reduced.
Stakeholders suggest ways FDA can develop a list of pre-DSHEA dietary supplement ingredients or express concern that building such a list would take t...
FDA clears a Camber Spine 510(k) for the SPIRA-C Open Matrix Cervical Interbody device, an interbody fusion implant.
FDA approves a Sunovion Pharmaceuticals NDA for Lonhala Magnair (glycopyrrolate) inhalation solution (25 mcg twice daily) for the long-term, maintenan...
Senator Joe Manchin (D-WV) calls on FDA to adopt three policy changes through its Opioid Policy Steering Committee to reduce unnecessary and dangerous...
A CVM report shows a decrease in antimicrobials sales from 2015 through 2016.