Reuters details the story of a Lilly human resources officer at the firms Branchburg, NJ, facility who claims company officials ignored her reports of...
Sagent Pharmaceuticals recalls three lots of phenylephrine hydrochloride injection, USP (10 mg/mL) due to sterility concerns.
FDA clears a Qardio 510(k) for its QardioCore ambulatory electrocardiogram device for holter monitoring applications, including its use with a cloud-b...
Nine FDAers say FDA is doing better accounting for sex and gender differences in drug development.
The CDER Office of Prescription Drug Promotion cautions Biohaven Pharmaceuticals that a video interview for its Nurtec ODT contains false or misleadin...
Six former FDA commissioners urge President Biden to prioritize the nomination and confirmation of an FDA commissioner.
FDA begins reviewing an Idorsia NDA for its investigational daridorexant for treating adult patients with insomnia.
TSG Consulting hires former FDA lawyer Laurie Clarke to lead its medical device regulatory practice.