Senators Jack Reed (D-RI) and Shelley Moore Capito (R-WV) introduce a bipartisan bill entitled Innovation in Pediatric Drugs Act (S 4905) that would a...
Smiths Medical corrects software used in its CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pumps due to many issues that may occur if the device i...
Reed Smith attorney James Beck says companies hit by FDA for off-label promotion may challenge the agencys reasoning under the new Loper Bright Suprem...
Medtronic recalls (Class 1) its NIM Vital Nerve Monitoring System to conduct a product correction due to reports of false negative responses.
FDA warns Melville, NY-based Velocity Pharma that it has received and distributed adulterated eye drop products produced for it by a contract manufact...
FDA warns Chinas Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. about CGMP violations in its production of finished drugs.
Federal Register notice: FDA announces a 9/6 public workshop entitled Enhancing Diversity in Therapeutics Development for Pediatric Patients to discus...
The Justice Department says a Virginia man who pleaded guilty to distributing misbranded drugs via the Internet has been sentenced to two years in fed...