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American Conference Institute (ACI)

[Virtual Event] 25th Annual Conference on Drug & Medical Device Litigation - December 8th - 9th, 8:45 am - 5:45 pm EST

American Conference Institute (ACI) on

Join us as we celebrate the 25th Anniversary of ACI’s Annual Flagship Conference on Drug & Medical Device Litigation! ACI’s Drug and Medical Device Litigation has united the greatest minds of the pharmaceutical and medical...more

Searcy Denney Scarola Barnhart & Shipley

Is the FDA Broken? — Uloric Cardiac Risk Issues

Searcy Denney Scarola Barnhart & Shipley on

Was Uloric Approval the Safe Decision? Attempts in 2005 and 2006 to obtain government-approval to sell Uloric were denied by the FDA due to concerns about research data that showed a slight elevation in the risks of death...more

Butler Snow LLP

Pro Te: Solutio – Vol. 11, No. 2

Butler Snow LLP on

In this issue of Pro Te (Volume 11, No.2), we examine three important topics with practical implications. In many jurisdictions, the medical judgment of physicians is almost sacrosanct – at least insofar as it is...more

Holland & Knight LLP

Right to Try Law Enacted by Congress: Implementation Unclear

Holland & Knight LLP on

On May 30, 2018, President Trump signed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2018. The bill allows the provision of certain unapproved, investigational drugs to patients...more

Verrill

"Right to Try" Comes to the Federal Stage: What Stakeholders Should Do Now

Verrill on

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

Mintz - Health Care Viewpoints on

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

Goodwin

JAMA Article: Obstacles to the Adoption of Biosimilars for Chronic Diseases

Goodwin on

Generic drugs currently account for 88% of all U.S. prescriptions, yielding 10-year cost savings in excess of $1.5 trillion. There is some optimism that biosimilars will offer a similar low-cost therapeutic alternative to...more

Goodwin

Missouri Governor Signs Biosimilar Substitution Law

Goodwin on

Last month, Missouri Governor Jay Nixon signed into law Senate Bill 875, allowing pharmacists filling prescriptions for brand name biological products to substitute a less expensive biosimilar product if the biosimilar has...more

Knobbe Martens

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Knobbe Martens on

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

Morgan Lewis

Practical Implications from Amarin

Morgan Lewis on

Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more

Manatt, Phelps & Phillips, LLP

Health Update - July 2015

Manatt, Phelps & Phillips, LLP on

Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more

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