Tarver warns that US device supply chain vulnerabilities could harm patients
The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting ...
FierceBiotech1d
FDA’s device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
pharmaphorum2d
FDA competition seeks digital endpoints for Parkinson’s
The competition – on which more details are available here – is being run by the FDA’s Center for Devices and Radiological Health (CDRH) and the Office of Digital, and ties in with ongoing ...
pharmaphorum2d
Google gives ex-FDA digital health head Bakul Patel strategic role
He was also involved in the creation of the FDA's Digital Health Center of Excellence in 2020 and drawing up the Center for Devices and Radiological Health (CDRH) 2022-2025 strategic priorities ...
CBS News3d
FDA moves to ban Red 3, citing concern over cancer in some animals
The Food and Drug Administration announced Wednesday it had decided to revoke Red 3's authorization to be added to foods, over concerns about how the food coloring dye has been linked to cancer in ...
Izotropic Announces Team Leading Clinical Study Design and FDA Regulatory Submissions
New FDA Consultant is the former Director of the Division of Imaging, Diagnostics, and Software Reliability at the U.S Food ...
CNN3d
FDA bans red dye No. 3 from food, drinks and ingested drugs in the US
The US Food and Drug Administration has banned the use of red dye No. 3 in food, beverages and ingested drugs, more than 30 years after scientists discovered links to cancer in animals ...
CBS News4d
Food shoppers could see nutrition facts on the front, as FDA unveils proposed packaging rules
The Food and Drug Administration released on Tuesday its long-awaited proposal to require food manufacturers to put some nutrition facts on the front of packages, in a bid to nudge Americans and ...
UPI4d
New FDA proposal would put 'front-of-package' nutrition labels on food products
Jan. 14 (UPI) --The U.S. Food and Drug Administration hopes "front-of-package" labeling will better improve the American population's health, the FDA announced. "Food should be a vehicle for ...
WLWT2d
FDA approves Zyn nicotine pouches, citing health benefits for adult smokers
The decision doesn't mean that Zyn is safe, just less harmful than older alternatives.To win FDA authorization, companies generally must show that their products will reduce disease among adult ...
Reuters2d
Outgoing FDA chief flags online weight loss drug dangers
"If the price of these drugs was not so high, it wouldn't be such a problem." The FDA needs more support, Califf said. His comments contrast with those of Trump's nominee for health secretary ...
JD Supra4d
FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal ...