JD Supra (press release)

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JD Supra (press release)

 •  December 4

An undisputed crisis exists due to the absence of adequate labeling for pediatric oncology drug products. Almost all drugs used to treat pediatric oncology patients were approved over decades ago and knowledge of pediatric cancer has increased logarithmically since their initial approvals. Further, the drugs were never tested in pediatric patients...

JD Supra (press release)

 •  November 16

The step of identifying an initial lead drug candidate is the cornerstone of the drug development process and is also usually the point at which actions are taken to protect the associated intellectual property (IP). However, is this the best time to be filing patent applications? What other factors need to be taken into account when an IP strategy...

JD Supra (press release)

 •  October 23

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a potential Brexit transition period. Speaking at the Drug Information Association (DIA) forum for EU QPPVs that took place on 4 and...

JD Supra (press release)

 •  October 17

Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents innovative, life changing and lifesaving products from reaching the public. Most of this criticism has been targeted at the federal Food and Drug Administration, which under the Trump...

JD Supra (press release)

 •  September 11

Most people are by now familiar with prescription drug TV ads that provide lengthy (and often confusing) laundry-list descriptions of numerous potential safety risks (seemingly regardless of the severity or likelihood of the risks). Indeed, direct-to-consumer (DTC) drug advertisements have become staple fodder for stand-up comedians and a recurring...

JD Supra (press release)

 •  August 15

Digital information has taken over our day-to-day lives, and the federal Food and Drug Administration (FDA) continues to recognize that this includes many aspects of our health care as well. This is clearly demonstrated by the set of initiatives established by the FDA that will directly impact how new, disruptive, and innovative products and...

Late last week, the US Food and Drug Administration (FDA) published its Digital Health Innovation Action Plan (Plan). The agency recognized that the traditional regulatory approach toward moderate and higher risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health...

While Congress and the White House continue to make statements about the need to rein in drug costs, several states are enacting legislation or regulations that offer the greatest opportunity to remake practices that are often depicted as abetting spiraling drug costs. Following the passage of such laws in Vermont and Maryland, other states are...

It appears that – at least for now – the U.S. Food and Drug Administration (FDA) is serving as the public face of the executive branch’s efforts to tackle the increasingly contentious debate about prescription drug prices. As we previously reported, following a May 25, 2017 budget hearing, FDA Commissioner Scott Gottlieb has made increased...

FDA Warning Letters focus on inaccurate drug product listings. Over the last year, the US Food and Drug Administration (FDA or Agency) has increased its enforcement efforts concerning drug product listing requirements, resulting in a number of Warning Letters for what appear to be simple errors in electronic submissions of drug product...