It is important to consider current FDA guidance and past enforcement actions as digital media becomes a larger space for pharmaceutical promotion aimed at healthcare providers and consumers. Strategizing for and developing  promotional materials for digital platforms should be thoughtful and deliberate given the limited scope of guidance available from the FDA. This article presents an overview of the available FDA guidance and enforcement actions for digital promotion an...

There is no specific definition in the People’s Republic of China regulatory framework clarifying the term “digital health,” but there is general acceptance that the term refers to digital technologies applied across the healthcare sector. 1,2 This article describes recent updates to the regulatory framework for digital health applications that qualify as medical devices under China’s regulations.   Keywords – China, digital health, regulatory   Introduction...

Updated 3 November 2022* The discovery of novel nitrosamine impurities in pharmaceuticals, coming after the valsartan/nitrosamine crisis of 2018, has caught global regulators and industry by surprise as more products than anticipated are affected by these impurities.   The situation raises new questions about how to set daily acceptable intake limits for pharmaceutical products when toxicological data on these impurities is scarce.   These novel nitrosamines, ...

Personalized nutrition is founded in evidence-based science and draws on individual-specific information to help consumers promote positive, sustainable dietary behavioral change resulting in measurable benefits in health improvement and maintenance, or disease-specific benefits. This article provides a comprehensive definition of personalized nutrition and examines its regulation globally and in the EU in regard to data protection, product qualification, and claims.   ...

As we enter the third year of the COVID-19 pandemic, consumers are increasingly turning to dietary supplements to help them manage the daily stress of this unprecedented time. However, as demand for dietary supplements associated with stress and anxiety-reduction has increased, so has regulatory scrutiny from the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC). This article provides an overview of the FDA and FTC’s regulations and enforcement activ...

The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going forward and has renewed calls for industry to embrace digital technologies and decentralized models for conducting clinical trials. The pandemic has also prompted the agency to re-evaluate its hiring practices, and to adopt the use of alternative tools in lieu of onsite inspections, which have become a permanent fixture in the agency...

Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...

The digital health sector is experiencing enormous growth globally. Briefly, digital health is a branch of healthcare that is primarily focused on improving health using internet, digital, and mobile technologies. One such novel subclass of the digital health ecosystem is digital therapeutics (DTx). DTx are “software-driven,” nonpharmacological therapeutic interventions that can improve the accessibility and effectiveness of healthcare. This article explores the current di...

While a lot of researchers claim they are capturing digital biomarker data, they may in fact be collecting clinical outcomes assessment (COA) data according to some US regulators. To clarify the differences, top US Food and Drug Administration (FDA) officials have defined digital biomarkers versus other kinds of data in a new article.   According to FDA officials in an article published on 25 March in npj Digital Medicine , a digital biomarker is “a characteristic o...

A number of stakeholders have written to the US Food and Drug Administration about the agency’s recent draft guidance on how digital health technologies (DHT) could be used to conduct clinical trials remotely. Some have concerns about the agency too narrowly defining what products can be used for remote monitoring, while others argue it’s not broad enough. Some are also asking the agency to include smart packaging in the guidance.   In December, the agency published i...

The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...

Over the last decade, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada (HC) have gotten better at disclosing previously confidential clinical data, a study published in The Journal of Law, Medicine & Ethics has found.     However, each agency discloses this data in a variety of different ways, according to Alexander C. Egilman, with the Center for Outcomes Research and Evaluation at Yale–New Haven Hospital in New Haven, CT,...