FDA Roundup: November 26, 2024
Regulatory2024-11-26
84 Views
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Monday, the FDA issued this guidance: Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices which provides a transitional enforcement discretion policy for manufacturers of certain Class III devices to respond to anticipated changes in ethylene oxide (EtO) sterilization activities. The guidance helps to prevent or mitigate the potential risk of medical device supply chain disruptions or shortages during the time period in which sterilization facilities are transitioning to comply with new Environmental Protection Agency requirements. This guidance is being published as part of the FDA’s efforts to mitigate potential impacts on the supply of sterile devices due to potential, actual, or temporary stops or reductions in operations at sterilization facilities that use EtO as a medical device sterilant.
- On Friday, the FDA approved Attruby (acoramidis) to treat adults with cardiomyopathy (disorder that affects heart muscle) of wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems. ATTR-CM is a rare and serious disease that affects the heart muscle. Recommended dosing for Attruby is available in the prescribing information.
- On Friday the FDA updated the advisory for the outbreak of E. coli linked to whole and baby organic carrots from Grimmway Farms. On November 21, 2024, the recall was expanded to include additional bag sizes for organic whole carrots under the following labels: to include additional bag sizes for organic whole carrots under the following labels:
- Bunny Luv: 50-lb
- Cal-Organic: 15-lb and 50-lb
- Good & Gather: 1-lb
Related Information
###
Boilerplate
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
Inquiries
- Consumer:
- 888-INFO-FDA
Source: U.S. Food and Drug Administration (FDA.gov)
The news, reports, views and opinions of authors (or source) expressed are their own and do not necessarily represent the views of CRWE World.
