Month: January 1970

ISSUE:  FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants.  At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.  BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.  The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.

The U.S. Food and Drug Administration (FDA) announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. FDA Commissioner Scott Gottlieb, M.D. announced today the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.

As our world becomes more interconnected, so do our medical devices:  we are connecting devices such as insulin pumps and glucose meters to apps, some of which also have cloud connectivity, enabling patients to share their health data with caregivers and loved ones.  However, this increased interconnectivity comes with vulnerability to cybersecurity threats.

The medical device industry should not treat cybersecurity as though it were a check box—and they may want to brush up on FDA’s role, says Seth Carmody, PhD, cybersecurity program manager at FDA.

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.

If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010.

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.

Researchers may have discovered a method of detecting changes in the eye that could identify Parkinson’s disease before its symptoms develop.  Scientists at University College London (UCL) say their early animal tests could lead to a cheap and non-invasive way to spot the disease.

As part of the 14th round of ongoing negotiations of the Transatlantic Trade Investment Partnership (TTIP) between the US and EU, the European Commission has released a new proposal that would push for more collaboration on medical device regulations.

The US Food and Drug Administration (FDA) in July 2016 issued two draft guidance documents describing how the agency will restrict the compounding of drugs that are essentially copies of commercially available or approved drugs.