The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year. According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus , the number of regulatory requirements...

The European Medicines Agency (EMA)—Europe's equivalent to the US Food and Drug Administration (FDA)—says it stands ready, willing and able to help accelerate the evaluation of new medicines and vaccines meant to treat a global outbreak of the Ebola virus. Earlier this week, the agency said it was encouraging companies to apply for orphan designation for their products—a designation intended to accelerate the review of products by allowing companies to access thorough sc...

More than half of the US public believes that the US Food and Drug Administration (FDA) is doing a good or excellent job, according to a recent survey sponsored by the pro-regulation group Coalition for Sensible Safeguards. The survey, based on a nationwide survey in July 2014 of 700 likely voters from around the country, quizzed respondents on their views of the US government and its many regulatory agencies. Respondents were relatively split on their view of the fe...

A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products. Background The matter in question concerns a federal court case, Planned Parenthood v. Humble , challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by FDA....

In recent weeks the US Food and Drug Administration (FDA) has undertaken major steps meant to bring lab-developed tests (LDTs)—devices developed, tested and used within a single laboratory—under stricter regulatory controls. But now new questions are being raised about whether the agency is using the correct methods to enact those changes. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval thro...

One of the US Food and Drug Administration's (FDA) top medical device regulators, Christy Foreman, will soon be giving up her position to focus on tobacco regulation at the agency. In an announcement on 19 August 2014, FDA said that Foreman—now director of the Office of Device Evaluation (ODE), the office which oversees approval of all medical devices in the US—will soon assume a new, as-yet undefined role at FDA's Center for Tobacco Products (CTP). Foreman's last day...

Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might so...

Unless you've been living under a rock this month, you've undoubtedly heard about a massive outbreak of the Ebola virus in western Africa. The virus is poorly understood, exceedingly rare and, most importantly, incredibly deadly. But what you probably haven't heard about is how treatments for Ebola are regulated—an oversight we at Focus are keen to correct. In this Regulatory Explainer , we're taking a look at the regulations that surround the development of a pote...

The US Food and Drug Administration (FDA) announced Thursday that it plans to reverse a decades-old policy and begin regulating Lab-developed Tests (LDTs) more similarly to in vitro diagnostic devices (IVDs). Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and expensive pathway that requires clinical data to support an application—or a...

The US House of Representatives has voted in favor of a bill that would require the US Food and Drug Administration (FDA) to speed up its assessment process for new sunscreen ingredients that have been awaiting regulatory approval for as long as a decade in some cases. Background The bill, the Sunscreen Innovation Act (H.R. 4250) requires FDA legislators to speed up their review of sunscreen ingredients submitted under the Time-and-Extent Application (TEA) process. ...

India’s Central Drugs Standard Control Organisation (CDSCO) has released a slew of orders making a wide range of changes to the agency’s policies governing clinical trials.  New policies stated in the documents include: Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical; Investigators are limited to working on a maximum of three trials simultan...

In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices. The announcement comes more than three years after FDA down-classified MDDS devices from Class III ("high-risk") to Class I. Whil...