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CDER Office of New Drugs deputy director Peter Stein says the backlog of post-marketing requirements and commitments has been dras...[ Price : $8.95]
Stakeholders suggest ways FDA can develop a list of pre-DSHEA dietary supplement ingredients or express concern that building such...[ Price : $8.95]
FDA clears a Camber Spine 510(k) for the SPIRA-C Open Matrix Cervical Interbody device, an interbody fusion implant.[ Price : $8.95]
FDA approves a Sunovion Pharmaceuticals NDA for Lonhala Magnair (glycopyrrolate) inhalation solution (25 mcg twice daily) for the ...[ Price : $8.95]
Senator Joe Manchin (D-WV) calls on FDA to adopt three policy changes through its Opioid Policy Steering Committee to reduce unnec...[ Price : $8.95]
A CVM report shows a decrease in antimicrobials sales from 2015 through 2016.[ Price : $8.95]
FDA issues a draft guidance to help sponsors use a possible new approach to developing drugs to treat pediatric rare diseases.[ Price : $8.95]
FDA releases a FDA-483 with seven observations from an inspection at Indias Glenmark Pharmaceuticals.