June 27, 2019 The answer to the first question is pretty easy. These sales reps typically work for medical device companies such as Stryker, Medtronic or DePuy Synthes. Many surgeries, especially orthopedic trauma and cardiac procedures, require insertion of artificial joints or other hardware manufactured by these companies. But as to why they are present … Read more
June 25, 2019 The House Ways and Means Committee unveiled 10 DEC 2018 the untitled bill for tax relief that includes disaster relief and reforms to the Internal Revenue Service (IRS). However, it also takes aim at a number of tax considerations related to health care. Among these is a delay in the implementation of … Read more
June 20, 2019 When circulating tumor DNA fragments are placed in water, they begin to fold into 3D shapes different than DNA from healthy cells — driven by the dense clusters of methyl groups found along DNA molecules that have been reprogrammed by cancer. Those specific structures can then be separated from the solution by … Read more
June 18, 2019 Center for Drug Evaluation and Research (CDER) Director Woodcock said that the difference between years past, when FDA was viewed negatively, and now is that there has been a sort of scientific revolution, with biology being harnessed in novel ways and investments at NIH paying off. Oncology Center of Excellence Director Pazdur … Read more
June 13, 2019 The Agency’s Safety Communication is in response to reports in the scientific literature and elsewhere, including in the media and promotional materials, that describe surgeons and hospital systems that use robotically assisted surgical devices for mastectomy. In particular, the FDA said it was aware of some peer-reviewed publications reporting poor patient outcomes, … Read more
June 11, 2019 China’s State Administration for Market Regulation posted notice in November of a draft law to regulate vaccine production, distribution and use. China solicited feedback on the proposal until Nov. 25, 2018. Fines would be applicable when companies submit false test results, do not recall batches that failed testing, or for other violations. … Read more
June 06, 2019 The FDA however, wants to speed the process of moving an industry steeped in batch processing into “advanced manufacturing processes,” and so it is pitching in with money and guidance. “Drug makers won’t switch to these systems until we create a clear path toward their adoption, and provide more regulatory certainty that … Read more
June 04, 2019 The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) will collaborate on the regulatory response to threats, such as the Ebola and Zika viruses and other infectious diseases, both in the U.S. and abroad. “Bacteria and viruses don’t … Read more