Bioventrix Scores IDE Nod for Revivent TC August 23, 2017 The system eliminates the need for cardiopulmonary bypass or heart incisions, according to BioVentrix. Read More
FDA’s Expedited Programs Predict Better Drugs, But Companies Are Still Slow to Confirm Benefits, Researchers Say August 23, 2017 Drugs in multiple expedited review programs had nearly twice the gains of those granted access to a single program. Read More
Tandem Diabetes Care Begins Enrollment for Insulin Pump Pivotal Trial August 22, 2017 It will include 90 type 1 diabetic patients aged six and above. Read More
EMA Outlines Generic Drugmaker Decisions for Setting Dissolution Specifications August 22, 2017 The paper includes a decision tree for setting specifications based on dissolution over time. Read More
FDA Clears Dictum Health Portable Spirometry System August 21, 2017 The device is intended for use with pediatric and adult patients. Read More
For Emergency OK of Expanded Drug Access After Dark, Call Us, FDA Says August 21, 2017 The ultimate resort day or night is the CDER emergency coordinator on duty. Read More
China Shortens Device Clinical Trial Authorization Timelines August 18, 2017 Sponsors who submit documentation to provincial FDAs can begin trials immediately. Read More
Maryland Defends Price Gouging Law Against AAM Suit August 18, 2017 The AAM hopes the court will block the law before it takes effect Oct. 1. Read More
Camber Spine Technologies Wins FDA Clearance for Spinal Implant August 17, 2017 The series will be released in the U.S. in the coming months. Read More
Regeneron Shuts Down Respiratory Syncytial Virus Drug After Phase 3 Trial Fails August 17, 2017 Company executives expressed disappointment, but said the company has “a robust pipeline across many serious diseases.” Read More
FDA Finds GMP Deficiencies at Intra-Lock International August 16, 2017 The FDA pointed to the firm’s failure to follow up on a packaging problem. Read More
FDA Provides Guidelines for Expanded-Access Applications August 16, 2017 The agency provided information on how to report results. Read More