FDA grants AstraZeneca six months pediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol.
FDA clears a Zeltiq Aesthetics 510(k) for the CoolSculpting device and its use for removing fat on upper arms.
BioMerieux expands an 8/2016 Class 1 recall of its NucliSENS easyMAG Magnetic Silica (MagSil) because of effects on nucleic acids extraction performan...
American University taps former HHS secretary Sylvia Mathews Burwell (Obama Administration) as its new president.
An FDA-483 shows an equipment cleaning procedure deviation from CGMP at Aurobindo Pharma in Borpatla, India.
FDA clears a DePuy Synthes 510(k) for the Viper and Expedium Fenestrated Screw Systems.
Two ranking democrats on the House Energy and Commerce Committee and the Oversight and Government Reform Committee call for a rescission on White Hous...
The CDER Office of Pharmaceutical Quality issues a MAPP on reviewer use of three foreign drug compendia when looking at CMC sections of INDs or NDAs.