If it looks like a medical device and it works like a medical device, it’s probably a medical device.
App developers, the wait is over! The FDA has finally released its guidance on mobile medical applications. The guidance describes the types of apps that are covered under FDA oversight and those left to the discretion of app developers. Continue reading
Regulatory affairs groups in the pharmaceutical industry have been going through a fast-paced evolution over the past 10 years. It wasn’t that long ago that these groups were almost taken for granted in the industry. Recently, however, this role has been changing substantially from simply getting a drug approved to being involved much earlier in the development process and asked to significantly influence the final product. Continue reading
In recent years, environmental concerns have made their way to the forefront of current issues — supported by scientists and politicians alike. As far as pharma is concerned, environmental regulations are nothing new. Continue reading
Even in the land of the free, there are some things you are not allowed to say. Schenck v. US (1919) proved that you can’t falsely yell “Fire!” in a movie theater. And when it comes to a product claim, the FDA has made it clear that if the agency hasn’t approved it, you can’t say it. But new FDA rules may extend these restrictions beyond mere words. According to a recent FDA draft guidance, the administration not only cares about what the product label says, but also what it looks like. Continue reading
Last month, the French version of the U.S. Sunshine Act was implemented, forcing medical device makers to report all exchanges of value to healthcare professionals in excess of €10, in a first step that will eventually spread to all life science companies. The French “Law No. 2011-2012 on Strengthening of Health Protection for Medicinal and Health Products” is retroactive to transactions from January 1, 2012. We believe a similar scenario as the one that unfolded in the US will prevail in France: a reduced pool of thought leaders available to work with device makers.
Regardless of company size, establishing operations to support expansions in new territories has a big impact on existing organizational structures. The question often rests on how the subsidiary will be connected to the headquarters. Will it be a centralized or decentralized operation? How independent does this operation need to be based on distance, time zone, cultural aspects, size and/or budget? Mix these factors, in addition to regional capabilities, and headaches will result for even the most experienced executives. Continue reading
There has been much buzz about the Sunshine Act since the Centers for Medicare and Medicaid Services (CMS) released its final draft of guidelines. Comparatively, there has been little mention as to how this legislation will affect individual states. According to Section H of the guidelines, the law will take precedence over existing state laws in situations where the national and state reporting requirements overlap. Continue reading
The Affordable Care Act’ (ACA) ride through legislative and judicial hurdles has focused on the high profile aspects of the law including the insurance mandate and state Medicaid responsibilities. However, one part of the law that will have a major impact on both patients and pharmaceutical sales forces is the establishment of accountable care organizations (ACOs) that bring physicians, hospitals and pharmacies together to create a more cohesive healthcare package for patients. This means that doctors would be made aware of potentially conflicting medications a patient may already be taking and be able to recommend a less risky course of a treatment. Continue reading
Many small pharmaceutical companies and biotech manufacturers continue to struggle with FDA approval delays that have developed over the past several years. Even internationally, regulatory guidelines have evolved to the point of being outright onerous in some countries. Many companies are adding substantial numbers of regulatory affairs personnel, preferably of the very experienced variety, to deal with the increased issues. Continue reading
Our recent research suggests intensifying competition among pharmaceutical companies for capable regulatory affairs employees. In fact, experienced regulatory affairs personnel can be counted as a white hot commodity right now. Executives that I have talked with at pharma companies said that hiring experienced regulatory affairs people is important for a number of reasons beyond simply understanding the process and how to fill out the correct documentation. Continue reading