Tag Archives: approval

FDA and CMS: A Partnership On Approval

By Julian Upton | Published: September 22, 2010

FDA announced last week that the lengthy delay that punctuates the initial approval of a medical product and it reaching the hands of consumers is to be addressed in a planned project in which the Agency will make joint approval decisions with the Medicare division of the Centers for Medicare and Medicaid Services (CMS). The [...]

Posted in FDA, Regulatory | Also tagged FDA, Medicaid, Medicare, Regulatory | 2 Comments

Post-Approval Regulatory Priorities: Progress or Pile-Up?

By William Looney | Published: May 25, 2010

An enduring falsehood about the pharmaceutical industry is that the heavy lifting ends with a successful new drug registration. What comes after is the equivalent of a well-funded retirement, where providers embrace the therapy, payers meet the price, and patients push the boundaries of clinical practice toward lucrative new indications. The reality, however, is starkly [...]

Posted in Regulatory | Also tagged Celebrex, FDA, Geodon, Harvard Medical School, post-approval strategies | 1 Comment