China’s FDA published (Chinese) a slate of suggested amendments to its foreign drug registration rules on Friday, March 17, 2017, aiming to speed up approvals, and pharma companies quickly hailed the changes.
The US Food and Drug Administration (FDA) on Friday, June 2, 2017 notified medical device labelers that it is extending the compliance dates for certain unique device identifier (UDI) requirements for Class I and unclassified devices.
When it comes to predicting who is at risk of suffering a heart attack or other major cardiac events, physicians have long relied on detecting high levels of C-reactive protein (CRP), an inflammatory biomarker. However, new research suggests CRP may not be the only game in town.
Healthcare is one of three industries facing the highest risk of a cyberattack in 2017, particularly as patient records and medical devices have become more interconnected.
Kim Kardashian is back on social media plugging for pharma. But unlike her Instagram post two years ago for Duchesnay’s antinausea drug Diclegis, which resulted in an FDA warning letter, this #Ad includes an extensive laundry list of potential side effects.
The World Health Organization has drawn up a list of the 12 resistant bacteria most problematic to human health—and called on governments and industry to step up efforts to find new medicines to fight them.
A new survey of U.S. scientists, FDA researchers and biomedical clinicians has found that most are concerned over FDA Commissioner nominee Scott Gottlieb’s long list of ties to biopharmas, with the majority also believing that proposed cuts to the National Institutes of Health (NIH) would hurt drug discovery.
One thing that is important to know about autism up front: There is no cure for autism. So, products or treatments claiming to “cure” autism do not work as claimed. The same is true of many products claiming to “treat” autism or autism-related symptoms. Some may carry significant health risks.
The U.S. Food and Drug Administration in April allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.
It has been said over and over by Pharma execs forced to defend high prices: A complex, opaque pricing and distribution system in the U.S. has helped drive up drug costs. Now, a new report commissioned by industry group PhRMA lends statistics to that argument.