Author Archives: Guest Blogger
Drug Shortages Still in Focus
By Patricia Van Arnum.
Drug shortages, particularly those for sterile injectable drugs, took center stage last year. In response, industry and the federal government, including FDA, took steps to address the problem. Progress has been made, and Congress is further evaluating if additional steps need to be taken.
Posted in Guest Blog, Regulatory Tagged AMA, drug shortages, FDA, HELP, Margaret Hamburg Leave a comment
Less is More: HHS Austerity Care
By Tom Norton
As the US Department of Health and Human Services (HHS) circles around the elements of health care that will actually be included in our new “Essential Health Benefits” (EHB), one aspect of the EHB offering has caused a tremendous stir among dozens of health groups. Their collective concern is focused on the pharmaceutical [...]
Posted in Guest Blog, Legal, Regulatory, compliance, healthcare Tagged Affordable Care Act, formulary, health insurance, healthcare reform, HHS, Managed care, Obamacare, policy, Regulatory Leave a comment
U.S. Biosimilars Under Threat?
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.
Posted in Biotech, FDA, Guest Blog, IP, Legal, Regulatory, Strategy, Technology Tagged biosimilars, FDA, Legal, Regulatory Guidelines 1 Comment
The Digital World is Changing Fast. Can You Keep Up?
by Ritesh Patel, global head of digital at Chandler Chicco Companies
I’ve been doing this digital thing for some time now. I’ve been part of and witnessed many changes in our digital world. However, I have never seen such a swift pace of change and digital adoption of late. It’s stunning how quickly things spread and [...]

Taxing Times for French Pharma