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The FDA’s Guidance on Labels and Cartons: yet another attack on pharmaceutical trade dress?
In the Guidance, the FDA posits that poor pharmaceutical label design can contribute to medication errors. To reduce such errors, the FDA seemingly takes a "pro-trade dress" stance by warning ...
FDA to issue new vaccine approval guidance amid questions over coronavirus shots
FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...
The FDA has a new definition for 'healthy food,' stripping the label from some yogurts, breads, and fruit cups that have hidden sugars
Under the previous FDA rule, which is being updated for the first time in 30 years, foods like salmon couldn't be labeled ...
STAT5h
FDA commissioner says new vaccine ‘framework’ for industry is coming within weeks
A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...
The National Law Review4mon
FDA Releases Draft Guidance on Plant-Based Food Labeling
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation ...
FDA to issue new vaccine framework within weeks
FDA to release new guidance soon, clarifying its regulatory framework related to vaccines, particularly COVID-19 shots. Read ...
Hosted on MSN1mon
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
The FDA announced Monday that it has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labeling of these electronic medical ...
Quality Assurance & Food Safety6d
FDA Extends Front-of-Package Labeling Comment Period
The deadline for comments on the proposed rule has been extended to July 15. The U.S. Food and Drug Administration (FDA) is ...
Food Safety News6d
FDA delays implementation of rule that would require new nutrition labeling
The FDA is delaying implementation of a rule that would require food companies to print nutritional information on the front labels of their products. The ...
pharmaphorum3d
FDA issues first guidance on AI in medicine development
The draft guidance – which is open for comment until 7th April – proposes a risk-based assessment framework that drug developers ... such as user interface and labelling, data management ...