Researchers question Gottlieb ties, balk against NIH cuts

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.

Autism: Beware of Potentially Dangerous Therapies and Products

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.

FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions

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.

Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs

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.

FDA Office of Regulatory Affairs Realignment to Begin in May

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.