Category Archives: FDA
Will Congress Provide Sequester "Flexibility" for User Fees?
Just about every federal program and affected interest group is pressing for relief from the 8% across-the-board cuts in funding imposed by the budget sequestration mandate. Recent fast action on Capitol Hill to curb personnel furloughs of air traffic controllers by the Federal Aviation Administration, though, has spurred lobbying for similar treatment across many fronts.
Also posted in Legal, Regulatory, healthcare Tagged FDA, Margaret Hamburg, Office of Management and Budget, sequestration Leave a comment
PCORI Launches Clinical Research Network to Support Trials, Outcomes Research
The new National Patient-Centered Clinical Research Network funded by the Patient-Centered Outcomes Research Institute (PCORI) aims to provide patients and clinicians with useful information on treatment options and outcomes. By encouraging more comparative clinical effectiveness research (CER), the program also has potential to support development of new drugs and devices, explained PCORI executive director Joe [...]
Also posted in healthcare Tagged CDER, CER, Clinical Trials, comparative effectiveness, EHRs, FDA, Janet Woodcock, John Castellani, outcomes, Patient Centered Outcomes Research Institute, patient information, PCORI, PhRMA, PPRMs, Sentinel Leave a comment
For Becton Dickinson, Medication Errors are a Business Opportunity
Over the next few years, med tech company Becton Dickinson will launch up to 30 generic, pre-filled syringes in an attempt to lower medication errors and raise company revenues, according to BD Rx president Mark Sebree.
One man’s goof is another man’s growth, potentially.
Also posted in Manufacturing, R&D, Safety, Strategy, Technology, pricing Tagged Becton Dickinson and Company, Medical Devices, medical supplies, medication error, payers, pre-filled syringes Leave a comment

FDA: From Risk Aversion to Approval Activism