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.
Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday, April 4, 2017 that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts.
The US Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA), which carries out the agency’s inspection program, will officially begin a major overhaul in the coming weeks, according to FDA’s Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.
Scott Gottlieb’s close links to the pharma industry have threatened to undermine his chances of becoming FDA commissioner—but he thinks he has a solution.
How would a “competitive bidding process” for drugs work? We may soon find out, if President Donald Trump gets his way with the Republican healthcare bill.
President Trump released his first budget blueprint last week, calling for FDA user fees to rise to more than $2 billion for fiscal 2018 — up from the $1.36 billion set for 2017 — and for $1 billion to fund the 21st Century Cures Act.
Even as the new administration is promising to sweep away some FDA practices to speed drugs to market, a new study has found that there has been a dramatic rise in the number of drug side effects reported in recent years.