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Forbes.com: The FDA Did The Right Thing, Mostly

On September 19, the FDA announced that eteplirsen (Exondys by Sarepta Therapeutics) received accelerated approval for the treatment of patients with Duchenne Muscular Dystrophy (DMD). During its development, the drug garnered Fast Track Designation, Priority Review, and Orphan Drug status from the FDA. Read More…

Sep 26 2016|Media|

Selfless Caring is what millennials want

Selfless caring is based on a moral belief system that demands that principles and truth are your highest goals and that taking personal responsibility is your defining quality. Selfless caring drives you to leave people and circumstances better than you found them. It is a virtually limitless source of energy that fuels tireless preparation and [...]

Aug 30 2016|Blog|

Inc.com: 3 Ways Millennials Made Me a Better Manager

Much has been written about the difference between Millennials and preceding generations in the workforce. Typically, these pieces mock certain behaviors of the group that will make up 75 percent of the U.S. workforce by 2030, and lament the “good ol’ days” of managing people who “get it.” Read More…

Aug 30 2016|Media|

Forbes.com: Pharmaceutical Compounding

Over the past few weeks, the FDA has devoted lots of attention to compounding pharmacies, issuing two new guidance documents pertaining to their fundamental scope, a guidance document regarding insanitary conditions, and revised inspection procedures. Given some recent high profile safety problems, including patient deaths as a result of contaminated sterile compounding products, the FDA has come under great scrutiny. But, it is not the FDA’s fault. Read More…

Aug 30 2016|Media|

MI³™ Alert: Compounding Pharmacies

According to the FDA, the term “compounding includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug” (21 USC 353b – The Compounding Quality Act or Drug Quality and Security Act of 2013). Compounded drug products serve an important role for patients whose [...]

Aug 9 2016|Medical Innovation Impact Index Alerts|

Money for Lunch with Bert Martinez: Dr. Joseph Gulfo on Innovation Breakdown

Joseph Gulfo joins Bert Martinez on the Money for Lunch segment on Blog Talk Radio. Read More…

Aug 3 2016|Media|

MI³™ Alert: Congressional Oversight of the FDA

Congress certainly expends great effort passing laws that have the goal of enhancing medical innovation, for example PDUFA (Prescription Drug User Fee Act) and MDUFA (Medical Device User Fee Act) reauthorization. The question is whether better Congressional oversight would result in a greater number of more profound medical innovations reaching patients more quickly. Download the [...]

Dec 1 2015|Medical Innovation Impact Index Alerts|

MI³™ Alert: Medicare Negotiating Drug Prices

Should Medicare be empowered to negotiate directly with pharmaceutical companies as one large buyer, instead of through many individual plans? Should Medicare be empowered to force the types of discounts that Medicaid and the VA receive? What are the implications for medical innovation? Download the full MI³™ Alert [PDF]

Oct 30 2015|Medical Innovation Impact Index Alerts|

MI³™ Alert: Off-Label Drug Use and Promotion

This MI³ Alert scores off-label drug use and promotion. Off-label drug use entails the prescribing of an approved drug for use in a manner that is not specified in the FDA's approved label, or package insert. Off-label promotion is defined as the intention (encouragement of physicians and advertising) of a drug manufacturer to have its [...]

Sep 16 2015|Medical Innovation Impact Index Alerts|

MI³™ Alert: PDUFA/MDUFA 2017 Reauthorization

This MI³™ Alert scores PDUFA/MDUFA 2017 reauthorization. User fees are payments collected by the FDA from companies submitting drug, biologics, and medical device applications for review and clearance, as well as for the establishments at which they are produced. They were authorized under the Prescription Drug User Fee Act (PDUFA – 1992) and Medical Devices [...]

Aug 25 2015|Medical Innovation Impact Index Alerts|