The FDA is continuing to make progress towards precision health care. According to a new report from the Personalized Medicine Coalition (PMC), more than 1 in 4 drugs approved over the past 4 years have been a personalized medicine. Find out more here. (Source: Laurie Toich, Specialty Pharmacy […]
Former FDA Commissioner on the FDA and RWE
Former FDA Commissioner, Robert Califf, MD, was recently interviewed ahead of the upcoming Data, Evidence and Access Summit 2017, on his views on the prevalence of real world evidence (RWE) and the Food and Drug Administration (FDA)'s acceptance of it. Find out more here. (Source: James Mackintosh, […]
FDA Urged to Further Loosen Limits on Data Exchange
In comments on the FDA's January 2016 draft payer communication guidance, stakeholders argued the need for further loosening restrictions on information exchange, and also seeked more clarity on how FDA will handle information exchange related to unapproved off-label uses of approved products. Paid […]
Gottlieb: Reducing Costs of Drugs Important Goal for FDA
The new Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, says that even though the agency does not have a direct say in pricing, reducing pharmaceutical costs will be an important goal for the agency. Find out more here. (Source: Richard Staines, pharmaphorum, 5/18/17) […]
Real-World Challenges of Real-Word Evidence
As real-world evidence (RWE) makes it's way into the health care system, the world of oncology has presents its own unique set of challenges. Find out more here. (Source: Managed care, May 2017) […]
Follow-up Studies are MIA for FDA Approved Drugs
A recent study was conducted, examining drugs approved by the Food and Drug Administration (FDA) between 2005 and 2012 on the basis of a single pivotal trial. Researchers sifted through medical literature searching for follow-up, or post-approval studies - this is what they found. Subscription […]
Gottlieb’s Views on ‘Gold Standard,’ Right-to-Try, LDTs, User Fees, FSMA & More
FDA Commissioner nominee, Scott Gottlieb, describes his views on regulations and gives a few hints on things that he would support if his nomination were to go through. Paid subscription required to read more. (Source: David Lim, InsideHealthPolicy.com) […]
PIE Legislation Officially Introduced in Congress
The Pharmaceutical Information Exchange (PIE) Act of 2017 has recently been introduced by Rep. Brett Guthrie (R-KY). This bill aims to improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between […]
US Supreme Court to Weigh in on Biosimilar ‘Patent Dance’
In somewhat of a surprise decision, The US Supreme Court recently decided to to review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. Find out more here. (Source: Zachary Brennan, RAPS, […]
What Would Gottlieb’s ‘Gold Standard’ Look Like?
During his recent confirmation hearing, Dr. Scott Gottlieb pledged to uphold a "gold standard of safety and efficacy" at the Food and Drug Administration. Gold standard sounds good for sure, however, what exactly does it mean? Subscription required to read more . (Source: Meghana Keshavan, STAT, […]
