FDA clears a Life Spine 510(k) for the Plateau-C Ti Cervical Spacer System.
FDA releases the FDA-483 with six observations issued after an inspection at ZS Pharma.
The Senate Health, Education, Labor & Pension Committee plans a 4/26 vote on Scott Gottlieb to be the next FDA commissioner.
CDER issues a list of 103 draft new and revised guidances it plans to issue this year.
Federal Register notice: FDA announces a 5/10 Medical Imaging Drugs Advisory Committee meeting that will discuss a NX Development Corp. NDA for a new ...
Federal Register notice: FDA announces a 5/24 Oncologic Drugs Advisory Committee meeting that will review two NDAs.
Federal Register notice: FDA announces a 5/25 Oncologic Drugs Advisory Committee meeting that will discuss a Hospira BLA for a proposed biosimilar pro...
FDA clears an Edwards Lifesciences 510(k) for its HemoSphere advanced monitoring platform that is intended to provide clinicians with information on a...