Category Archives: FDA

FDA: From Risk Aversion to Approval Activism

By Ben Comer | Published: May 7, 2013

During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news. On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based [...]

Also posted in Agency Insight, Biotech, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy, leadership | Tagged access, breakthrough therapies, CDER, Cole Werble, FDA, IMS, Rachel Sherman, Regulatory | 2 Comments

Will Congress Provide Sequester "Flexibility" for User Fees?

By Jill Wechsler | Published: April 30, 2013

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

By Jill Wechsler | Published: April 30, 2013

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

Ad Agency Encourages Pharma Marketers to Reboot

By Ben Comer | Published: April 16, 2013

People tell you who they are, but we ignore it – because we want them to be who we want them to be. – Don Draper At the beginning of the Reboot Camp – held at New York City’s Alexandria Center on April 12 – Intouch Solutions’ CEO Faruk Capan declared the days of Don Draper [...]

Also posted in Advertising, Agency Insight, Emerging Markets, Marketing, Patient Communication, People, Regulatory, Sales, Strategy, Technology, healthcare, leadership, patient education, social media | Tagged Agency, big data, Crossix, digital health, digital marketing, Fitbit, FuelBand, GE Healthcare, Happtique, Intouch Solutions, mHealth, mobile health, Sanofi | 1 Comment

For Becton Dickinson, Medication Errors are a Business Opportunity

By Ben Comer | Published: April 1, 2013

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