Regulatory Explainers


Understanding how healthcare products are regulated is difficult. Luckily, we—the editors of Regulatory Focus—have done some of the heavy lifting for you when it comes to some of the most common and controversial regulatory topics.

In each Regulatory Explainer, we describe a regulatory issue in plain terms, allowing you, the reader, to obtain a full understanding of a topic and its complexities.

[NEW 2017] Regulatory Explainer:FDA User Fee Reauthorizations 2018 to 2022
The new law reauthorizes FDA's ability to collect user fees from prescription drug, generic drug, medical device and biosimilar companies, in addition to a number of new provisions on what FDA must issue and how the agency must respond to industry. 

[NEW 2016] Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA
Lingering for more than two years, the House and Senate have agreed on a revamped bill that will overhaul the way in which pharmaceuticals, biologics, medical devices and combination products will be regulated by FDA moving forward. The bill will also provide FDA with $500 million in additional funds over the next 10 years.

[NEW 2016] Regulatory Explainer: Everything You Need to Know About Biosimilars 
For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption. 

[UPDATED 2017] Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
Since 2007, the US Food and Drug Administration (FDA) has issued a small handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in this Regulatory Explainer on the Priority Review Voucher system.

Regulatory Explainer: The 21st Century Cures Act
In 2014, the US Congress launched a process that is set to dramatically overhaul the manner in which healthcare products are regulated in the US, and in particular by the US Food and Drug Administration (FDA). In this Regulatory Explainer, learn more about the 21st Century Cures Act—the flagship piece of legislation being advanced by the House of Representatives' Energy and Commerce Committee.

Regulatory Explainer: FDA's Expanded Access (Compassionate Use) Program
Perhaps no area of FDA regulation attracts as much attention as FDA's "compassionate use" regulations, which describe the process by which dying patients can obtain last-chance medicine from pharmaceutical companies. It's a complex regulation with lots of nuance and even more importance to the patients who rely on it to stay alive. Learn everything you need to know about the program in our Regulatory Explainer on expanded access/compassionate use.

Regulatory Explainer: What You Need to Know About the Regulation of Ebola Treatments
A 2014 outbreak of the Ebola virus had many people asking how the US system of medical product regulation would be able to cope with a fast-moving and deadly disease with no known cure. In this Regulatory Explainer, we break down the various regulatory options available to US regulators in plain terms.

Regulatory Explainer: Making Sense of Humanitarian Use Devices
What's a Humanitarian Use Device (HUD), and how is it regulated? You might be surprised to learn that an HUD is basically just a fancy term for a device intended to be used to treat a rare disease, and even more surprised to learn that HUDs aren't required to prove to FDA that they're effective. Learn more about this little-known program in our Regulatory Explainer from March 2014.

Regulatory Explainer: Understanding the Regulation of Generic Drug Labels
You might not know it, but the labeling of generic drugs has for years been one of the single most controversial regulatory issues facing the US Food and Drug Administration (FDA) and the Supreme Court. At issue: If a generic drug company is made aware of a safety issue, can it update its label to list that issue? And can consumers sue a generic drug company if it doesn’t, even if the company legally can't update the label? Find out the answers and implications to these questions in this Regulatory Explainer on generic drug labeling.

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps?
It's a surprise to many outside the regulatory world that software can actually be regulated by FDA as a medical device if that software had explicit medical applications. And we're not just talking about the software embedded within a medical device, either—mobile apps capable of being run on your smartphone can also be medical devices under the law. So how does FDA regulate mobile apps? The answer might surprise you. Read all about it in our Regulatory Explainer on mobile apps.

Past Issues

Some of our regulatory explainers contain a lot of information, but are no longer up-to-date.

Regulatory Explainer: Understanding the Regulation of New Sunscreen Ingredients
This regulatory explainer, last updated in March 2014, explains how sunscreen ingredients were regulated in the US. Following the passage of the Sunscreen Innovation Act in late 2014, the way in which FDA is permitted to regulate sunscreen ingredients has changed significantly. Read all about the controversy which led to the passage of that law in our Regulatory Explainer on new sunscreen ingredients here.