Category Archives: News

Looking Into the Future: FDA’s 2011 Guidance Agenda

On December 7, FDA released its annual guidance agenda, which serves as a blueprint—almost a wish list— for what the organization plans to focus its time and resources on in the coming year. FDA’s good guidance practices regulations [GGP] require it to publish for public comment an annual summary of key priorities in the coming […]
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Federal Judge Declares Mandatory Health Insurance Unconstitutional

This new decision out of Virginia increases the prospect of a showdown between an elected Congress and President and the Supreme Court over the legality of this year’s health reform legislation affecting nearly one-fifth of the US economy. Resolution of the court case is unlikely before 2012—which is also an election year. Earlier this week, […]
Also posted in Legal | Tagged , | 3 Comments

Workforce Shortage in Oncology Imminent

Supply and demand for oncology specialists is expected to become even more unbalanced in the US market over the next 10 years, particularly as the new health reform legislation creates more uncertainty for the reimbursement of the high cost biologic treatments now coming on stream. Several survey are documenting the shortage and suggesting that the […]
Also posted in Agency Insight | Tagged | 2 Comments

Pfizer: A Sudden Change at the Helm

Pfizer veteran insider succeeds Jeffrey Kindler as CEO—with more to come Pfizer’s Board of Directors has elected Ian C. Read, currently head of the company’s global biopharmaceutical operations, as President, CEO, and director.  Read succeeds Jeff Kindler in a transition that was sudden and unexpected:  occurring on a Sunday night, by early Monday morning Kindler’s […]
Also posted in leadership, People | Tagged | 3 Comments

Commercial Use of Physician Information Law Overturned

The ruling is likely to force state legislatures considering such bans to reconsider or fine tune their approach, as the First Amendment right to communicate appears to have trumped more parochial concerns about saving money on drugs. The US Court of Appeals for the Second Circuit recently ruled that a Vermont law restricting the commercial use […]
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