jvgulfo

About Joseph Gulfo

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So far Joseph Gulfo has created 27 blog entries.

Journal of Medical Device Regulation: Can the US FDA be brought ‘back to the future’?

The 21st Century Cures Act was signed into law on 16 December 2016. Putting aside whether enough funds will be dedicated to enacting Food and Drug Administration (FDA) policies, is this the legislation that will bring the FDA back to its proper role of adjudicating safety and effectiveness, that is, ‘back to the future’? In [...]

Sep 9 2017|Media|

FDU: FDA Approval Delays for Drugs First Approved Abroad, and the RESULT Act by Eman Makar and Joseph V. Gulfo

This paper examines delays in FDA approvals of drugs that have been on the market abroad. As in-depth examples, we focus on domperidone (Part I) in treatment of gastroparesis and mifamurtide (Part II) for osteosarcoma. We discuss the RESULTS Act (Part III), a bill that would force the FDA to approve drugs that have been approved for marketing in countries with well-respected regulatory systems, as well as our recommendations (Part IV). To download the full paper, visit http://view2.fdu.edu/academics/pharmacy/lewis-center/ipci/policy-papers/download.aspx?id=22774  Read More…

Jun 2 2017|White Papers|

Real Clear Politics: Why the New FDA Chief Matters

A Life and Death Tale of a Life Saving Drug’s Journey to Market The week before last, with little fanfare, Dr. Scott Gottlieb was confirmed as the new leader of the Food and Drug Administration (FDA). Unlike other high profile nominees, not much ink or airtime was spent on his hearings or his ascent to [...]

May 24 2017|Media|

FDU: Product Approvability Recommendations from FDA Advisory Committees: Inconsistently Sought, Indirectly Obtained by Joseph V. Gulfo , Jason Briggeman , and Asmaa Gamie

Divisions within the Food and Drug Administration (FDA) often convene meetings of advisory committees, also known as AdComm or Panel meetings. The purpose of many AdComm meetings is for the FDA to obtain outside advice and recommendations on whether to approve a new drug or medical device. Laws and regulations indicate that such Panels are to provide recommendations regarding the approvability of the drug or device by FDA. In this paper we examine recent AdComm meetings to find whether FDA is obtaining Panel recommendations on drug and device approvability in accordance with these laws and regulations. Read More…

Apr 27 2017|White Papers|

Tonic: The FDA Might Pull The Only Treatment for a Rare Form of Muscular Dystrophy by Annamarya Scaccia

Advocates understand that eteplirsen is not a cure-all for Duchenne muscular dystrophy. But it's a start for a condition that has no cure. Joseph Gulfo, a biopharmaceutical expert and outspoken critic of the FDA drug approval process, believes that eteplirsen could be used in conjunction with other drugs, either on the market or on the horizon, similar [...]

Apr 19 2017|Media|

Pinkerton: What Trump’s ‘Great Healthcare Plan for the People’ Might Look Like via Breitbart News

... So here’s one idea, from Dr. Joseph V. Gulfo, MD, of Fairleigh Dickinson University’s Lewis Center for Healthcare Innovation and Technology.  In an interview, Gulfo summed up his idea in two words: wearable technology.  That is, let’s be sure that all our aging heroes in the VA system have access to the sort of ever-present [...]

Apr 3 2017|Media|

STAT News: Trump considers an entrepreneur with sweeping reform plans to run the FDA by Sheila Kaplan

WASHINGTON — Two weeks ago, Dr. Joseph Gulfo ran a panel at the Biotech Showcase in San Francisco titled, “The Trump Administration: What to expect from the FDA.” He left out one key detail: He may end up running the place. Gulfo, who may be the first person in political history to serve as a senior fellow at [...]

Mar 28 2017|Media|

The Hill: FDA critic on Trump’s shortlist to head agency by Sarah Chacko

(This story previously appeared in The Hill Extra) Former biotech executive Joseph Gulfo has been offering the Trump administration advice on how it could reshape the Food and Drug Administration. It seems the administration likes what he has to say. Gulfo, who sparred with the FDA over the approval of a medical device product from 2010 to [...]

Mar 27 2017|Media|

NJ.com: Trump eyeing N.J. college official for FDA job, reports say by Kelly Heyboer

TEANECK -- A Fairleigh Dickinson University official who wrote a book critical of the Food and Drug Administration is one of President Donald Trump's top choices to lead the federal agency, reports say. Joseph Gulfo, executive director of Fairleigh Dickinson's Lewis Center for Healthcare Innovation and Technology, is one of the names being vetted for the FDA commissioner job, according to [...]

Mar 26 2017|Media|

MedPage Today: Who Will Trump Pick to Helm the FDA? by Shannon Firth

WASHINGTON -- President-elect Trump has yet to announce potential candidates to lead the FDA, but several health policy experts shared their picks with MedPage Today. At least two names have been bandied about -- Scott Gottlieb, MD, a resident fellow with the conservative think tank, the American Enterprise Institute, and Jim O'Neill, a libertarian and [...]

Mar 25 2017|Media|