In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency issues an import alert against Jiangsu S...
Two stakeholders comment positively on an FDA public meeting on advancing the use of complex innovative designs in clinical trials.
CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in communications to healthcare providers may help them for...
An FDA inspection last month at Alkem Laboratories India manufacturing facility leads to a 10-observation Form FDA-483.
A federal court approves an FDA-brokered consent decree against Philips Respironics over its defective breathing devices.
FDA warns Mumbai, India-based Kilitch Healthcare India about CGMP violations in its production of sterile ophthalmic drug products.
FDA warns Jiangsu, China-based Jiangsu Meifan Biotechnology Co. about CGMP violations in the production of finished OTC drugs found in an agency revie...
FDA grants Phanes Therapeutics a fast track designation for PT217 and its use in treating patients with extensive-stage small cell lung cancer with di...
