Tag 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 [...]
Posted in Agency Insight, Biotech, FDA, Legal, Market Access, Orphan Drugs, People, R&D, Regulatory, Strategy, leadership | Also tagged , , , , , , | 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.
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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 [...]
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Safety Trumps Access to Pain Meds for FDA

By Guest Blogger | Published: April 17, 2013
By Jill Wechsler, Washington Correspondent. The Food and Drug Administration has come down on the side of reducing abuse of opoid medications, over encouraging wider availability of low-cost painkiller meds. The agency decided to block generic versions of the original OxyContin formulation, which is fairly easy to manipulate by illegal users. The aim is to help [...]
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Budget Cutters Propose Big Hits on Pharma

By Guest Blogger | Published: April 17, 2013
By Jill Wechsler, Washington Correspondent. The Obama administration’s budget plan for fiscal year 2014 apparently assumes that the pharmaceutical industry can support Medicare and other health programs through changes in drug coverage and payments. It also relies on industry fees to keep the Food and Drug Administration up and running. Meanwhile, FDA and other public health [...]
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