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Category Archives: Regulatory
Your 2014 Medicaid Sales & Marketing Plans
by Tom Norton
If you are an Rx regional sales director or a product marketing manager, I have a somewhat provocative question for you: How exactly are you planning your 2014 Medicaid strategy?
Also posted in Advertising, Guest Blog, Legal, Market Access, Marketing, Sales, Strategy, healthcare, pricing Tagged ACA, CMS, Florida, HHS, Medicaid, Obamacare, Regulatory, sales and marketing, state health exchanges, States, Texas Leave a comment
FDA: From Risk Aversion to Approval Activism
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, FDA, Legal, Market Access, Orphan Drugs, People, R&D, Strategy, leadership Tagged access, breakthrough therapies, CDER, Cole Werble, FDA, IMS, Rachel Sherman, Regulatory 2 Comments
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 FDA, Legal, healthcare Tagged FDA, Margaret Hamburg, Office of Management and Budget, sequestration Leave a comment
Drug Patents Under Fire in Brazil