Tag Archives: Regulatory Guidelines
By Ben Comer | Published: August 29, 2012
Last Friday, an appellate court upheld an earlier judgment allowing government to fund embryonic stem cell research for the development of new therapies. Biotechs and advocacy groups cheered the decision but uncertainty remains, in large part due to the possibility of a Romney administration in the White House.
By Guest Blogger | Published: April 27, 2012
by D’vorah Graeser, Graeser Associates International While the FDA continues to develop its guidance for U.S. biosimilars, including a one-day public hearing on May 11, 2012, the basic legal underpinnings of biosimilars in the U.S. may be under threat, as the Supreme Court debates the healthcare law, a large chunk of which includes provisions for biosimilars.
By Ben Comer | Published: April 5, 2011
It’s not yet clear whether physicians will rush to form accountable care organizations (ACOs) in light of newly proposed Centers for Medicare and Medicaid Services (CMS) guidelines, which are lengthy, but pharmaceutical companies hoping to do business with ACOs will have to show that expensive brand drugs can offer not just better health outcomes, but [...]