The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has approved nearly every Premarket Approval Application (PMA) it received for medical devices in 2015 and the spike may be linked to FDA’s improved assessment of PMA deficiencies earlier in the review process. The 98% approval rating in 2015 for PMAs is the highest FDA has seen in at least 15 years, and 8% higher than the next highest from 2005, according to a 371-page quarterl...

The claims of an anonymous whistleblower within the US Food and Drug Administration (FDA) that employees of the Center for Devices and Radiological Health (CDRH) created public health dangers by approving the use of a digital mammography device and several colonography devices were found to be unsubstantiated, according to a letter sent by the US Office of Special Counsel (OSC) to President Barack Obama. Background Six staff scientists, former employees of CDRH's Office...

On Monday, the US Food and Drug Administration (FDA) released a vast amount of medical device data to its openFDA platform. Background The openFDA initiative was originally born from an order from the White House , which called for federal agencies to implement a new " digital strategy " to make government information more accessible to the public. The strategy focused on creating APIs – not active pharmaceutical ingredients, but application program interfaces – that ...

In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...

Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...

Studying the history of regulatory approvals can provide insights into regulator expectations for new products. The authors undertook an investigation to examine the data sets on which previous US Food and Drug Administration (FDA) approvals for melanoma treatment products were based to determine whether trends have changed in the level of evidence provided. Melanoma was chosen due to its relevance to ongoing projects by the authors. Methodology The authors obtai...

According to a new survey, the US Food and Drug Administration (FDA) is in a lose-lose situation when it comes to regulating healthcare products. FDA's Lose-Lose Proposition The poll, sponsored by research advocacy group Research!America and conducted with help from Zogby Analytics, polled approximately 1,000 adults about their views on America's role in public health research and development. The research indicates, for example, that Americans are broadly in favor of ...

A new report issued by the consulting group PricewaterhouseCooper (PWC) indicates that the US Food and Drug Administration (FDA) is making sustained improvements to its drug and medical device approval processes, resulting in new products reaching consumers more quickly. PWC's report, The FDA and industry: A recipe for collaborating in the New Health Economy , is a wide-ranging look at FDA's performance and industry's assessment of its interactions with the regulator....

Six of the world's most preeminent regulatory bodies have become increasingly adept at approving new drug products more quickly and consistently, according to a new analysis published by the Centre for Innovation in Regulatory Science (CIRS). Background: Study CIRS' analysis looked at new drug approval decisions made over the past decade by six regulators: The US Food and Drug Administration (FDA) The European Medicines Agency (EMA) Japan's Pharmaceutical and Medica...

The US Food and Drug Administration (FDA) is touting the number of new molecular entities it has approved thus far in 2014, saying the numbers are indicative of a "strong year for novel drug approvals." A Strong Year for Approvals "With a few weeks left in December, our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel new drugs in 2014 compared to 27 in 2013," said FDA Commissioner Margaret Hamburg in a posting on the agency's FDA Voice blo...

The development of a new pharmaceutical or biopharmaceutical product is a notoriously difficult process. According to industry data compiled by the Tufts Center for the Study of Drug Development, only about one in 10 drugs entering into Phase I clinical trials will ever be approved by the US Food and Drug Administration (FDA)—and those are just the companies whose drugs actually made it to the clinical development stage.  Getting a drug approved, in other words, can feel ...

A new report published by the Tufts Center for the Study of Drug Development (CSDD) validates longstanding data indicating that drugs intended to treat disorders of Central Nervous System (CNS) take longer to develop and are rejected by US Food and Drug Administration (FDA) regulators at a higher rate than are other drugs. Background Disorders of the central nervous system are as diverse as they are challenging to treat. Some of the most common CNS disorders include dep...