An expert explain the various concerns that were holding up FDA approval – from potential harmful side effects, to protecting the privacy of users’ brain-wave data.
If you’ve worked in medical devices for a while, the term Device Master Record or DMR probably feels like muscle memory. It’s been part of the regulatory vocabulary for decades, especially if you’ve worked with U.S. Food and Drug Administration (FDA) requirements.
Gene Therapy Clinical Trials Regulatory Affairs
Regulatory and ethical issues of gene transfer are usually a secondary preoccupation of researchers. Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those…
New regulations have come into effect in the UK which place a greater emphasis on medical device manufacturers to monitor the safety and performance of their products. The new Post-Market Surveillance (PMS) regulations came into effect from Monday (16 June) requiring device manufacturers to actively track the safety and performance of products already in use. […] The post New medical device repor…
I think the FDA has been holding its breath on one level for about two years. How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them […] The post FDA wins big in key federal stem cell clinic court case appeared first on The Niche .
Over the last two years, China has updated some regulations on human genetic engineering and assisted reproduction and established a national committee to guide and supervise bioethics nationwide. But there are legal gaps in some of the regulations and tension between competing values: the desire to encourage new research and to potentially inhibit it by imposing stricter ethics regulations. The …
The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways […] The post One size doesn’t fit all? FDA may soften some cell therapy …
As you're no doubt aware, medical products are subject to incredibly strict guidelines, mandated and overseen by the Food and Drug Administration(FDA).
