Harvard Medical School researchers say it is difficult to determine whether FDA expedited drug review and approval programs have actually incentivized...
FDA clears a BioCardia 510(k) for the Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell...
CDRH consumer safety officer Vidya Gopal uses a Webcast to describe requirements in the production and process controls subsystem.
A Science investigative report details the large percentage of clinical trials that fail to meet legal requirements for submitting data and results an...
FDA warns Health Pharma about CGMP violations in its work as a contract manufacturer of finished drugs.
Ultragenyx Pharmaceutical and Kyowa Kirin file a supplemental BLA for Crysvita (burosumab) for treating FGF23-related hypophosphatemia associated with...
FDA releases its latest batch of Warning Letters that includes Health Pharma, Huaian Zongheng Bio-Tech and James W. Findling.
FDA warns Chinas Huaian Zongheng Bio-Tech about CGMP violations in its work as a contract producer of finished drugs.