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...
Federal Register notice: FDA announces a 5/9-10 workshop to obtain input on issues and challenges associated with federal efforts to support training ...
FDA clears an electroCore 510(k) for the gammaCore vagus nerve stimulator for treating acute pain associated with episodic cluster headache in adult p...
Federal Register notice: FDA and the Critical Path Institutes Patient-Reported Outcome Consortium announce a 4/25 public workshop entitled Second Annu...