Tag: innovation

innovation

Regulatory/FDA

New FDA Guidance on Clinical Trial Design—and an Admonition from Commissioner Gottlieb

New FDA Guidance on Clinical Trial Design—and an Admonition from Commissioner Gottlieb

March 18, 2019 — With mere days left before his departure as FDA Commissioner, Dr. Scott Gottlieb is trying to focus attention on one of the lesser-known of his major initiatives – improving the design of clinical trials in drug development. In a statement released along with the publication of a new guidance, Gottlieb highlighted […]

Read more

General

Guest Commentary: What Might a Part B IPI Model Do to Drug Innovation, Patient Care?

Guest Commentary: What Might a Part B IPI Model Do to Drug Innovation, Patient Care?

By Michael Parenti, Senior Engagement Strategist, Saatchi & Saatchi Wellness Feb. 1, 2019 — On Oct. 25, 2018, the Centers for Medicare and Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) to test whether phasing down the Medicare payment amount for selected Part B drugs to more closely align with international prices […]

Read more

PhRMA’s Hugin Hits Innovation Nail on the Head

July 2, 2013 – In a recent blog post on Drugwonks.com, entitled “The Ecosystem of Medical Innovation,” Peter Pitts forwarded some “solid directional guidance” from Bob Hugin, CEO of Celgene and the new Chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA). Hugin states that medical innovation is “the crown jewel of America and […]

Read more