Lori A Carr 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
May 31, 2019 Preference for digital channels has risen steadily since 2015, while the appeal of Sales Representatives has plateaued, Gaurav Kapoor, Indegene Co-Founder and Executive Vice President, said. One reason doctors want more digital contact? More administrative work leaves less time to see Sales Reps even as complex drugs require more education. That could … Read more
May 28, 2019 One question remains constant: How can we effectively treat pain, while reducing the ever-increasing numbers of opioid prescriptions flowing into U.S. homes? The answer is to eliminate or significantly reduce the need for opioids from the time that the pain occurs and when the first prescription is written. In a March 2017 … Read more
May 23, 2019 This idea had been in the back of Fenner’s mind for a while. Her son was diagnosed with Type 1 diabetes nine (9) years ago, meaning he needs daily injections of insulin to live. The list price of the modern generation of insulin has skyrocketed since his diagnosis. On one trip to … Read more
May 21, 2019 The cases are related to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma that can develop in the scar tissue surrounding an implant. The Agency first alerted the public to the risks of the disease in 2011, and has been tracking known cases of BIA-ALCL, deaths and risk … Read more
May 17, 2019 A study published in January 2019 in the Journal of the American Medical Association (AMA) adds to a growing body of evidence suggesting that human-derived formulations of insulin are as clinically effective at treating Type 2 diabetes as pricier “designer” analogues that get used more commonly. That could offer patients relief from … Read more