A Delaware federal judge says FTC may re-file a narrowed complaint against Shire to determine whether the companys many Vancomycin petitions to FDA we...
Medical device manufacturer Alere agrees to pay $33.2 million to resolve a whistleblower suit alleging that it knowingly sold diagnostic devices that ...
BIO asks FDA to clarify some aspects of a draft guidance on priority review vouchers for medical countermeasures.
FDA says it has allowed the marketing (de novo process) of the first fully interoperable continuous glucose monitoring system.
FDA approves a Novo Nordisk supplemental NDA for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcom...
Tamarack recalls Eclipse Kratom-containing powder products because they have the potential to be contaminated with Salmonella.
Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Secti...
FDA issues a guidance on Chronic Obstructive Pulmonary Disease: Use of the St. Georges Respiratory Questionnaire as a Patient-reported Outcome Assessm...